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Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
carboplatin
paclitaxel
thalidomide
radiation therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma Squamous cell Adenocarcinoma Large cell undifferentiated Bronchoalveolar Non-small cell carcinoma not otherwise stated Unresectable stage IIIA Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule out resectability OR Stage IIIB disease without significant pleural effusion Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1 thoracentesis and is cytologically negative Metastases to contralateral, mediastinal, or supraclavicular nodes allowed Bidimensionally measurable or evaluable disease 18 and over ECOG performance status 0-1 Adequate hematopoietic, hepatic, and renal function obtained <=4 weeks prior to registration: Platelet count at least 100,000/mm^3 White Blood Cell (WBC) count at least 4,000/mm^3 OR absolute neutrophil count at least 2,000/mm^3 Bilirubin normal Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper limit of normal Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy Concurrent filgrastim (G-CSF) allowed for persistent neutropenia Exclusion Criteria: Positive pregnancy test,pregnant or nursing Uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year Serious cardiac arrhythmias requiring medication Prior radiotherapy to only area of measurable or active tumor Less than 5 years since prior chemotherapy Other active malignancies Serious uncontrolled active infection Evidence of greater than grade 1 neuropathy by history or physical examination History of seizure disorders Contraindication to daily low-dose (81 mg/day) aspirin

Sites / Locations

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
  • Memorial Medical Center Cancer Services
  • Salinas Valley Memorial Hospital
  • Stanford Comprehensive Cancer Center at Stanford University Medical Center
  • Aurora Presbyterian Hospital
  • Boulder Community Hospital
  • Memorial Hospital
  • Penrose Cancer Center at Penrose Hospital
  • Porter Adventist Hospital
  • Presbyterian - St. Luke's Medical Center
  • St. Joseph Hospital
  • Rose Medical Center
  • CCOP - Colorado Cancer Research Program, Incorporated
  • Swedish Medical Center
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  • Sky Ridge Medical Center
  • Hope Cancer Care Center at Longmont United Hospital
  • St. Mary-Corwin Regional Medical Center
  • North Suburban Medical Center
  • Praxair Cancer Center at Danbury Hospital
  • William W. Backus Hospital
  • Halifax Medical Center - Daytona Beach
  • Baptist Cancer Institute - Jacksonville
  • Veterans Affairs Medical Center - Augusta
  • MBCCOP - Medical College of Georgia Cancer Center
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Medical Center of Central Georgia
  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Mercy Hospital and Medical Center
  • Swedish Covenant Hospital
  • Hinsdale Hematology Oncology Associates
  • Midwest Center for Hematology/Oncology
  • Trinity Medical Center - East
  • Swedish-American Regional Cancer Center
  • Hematology/Oncology of the North Shore at Gross Point Medical Center
  • Elkhart General Hospital
  • Howard Community Hospital at Howard Regional Health System
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • Reid Hospital & Health Care Services, Incorporated
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • Saint Joseph Regional Medical Center
  • Hematology Oncology Associates of the Quad Cities
  • St. Luke's Hospital
  • Cedar Rapids Oncology Associates
  • Mercy Regional Cancer Center at Mercy Medical Center
  • Genesis Regional Cancer Center at Genesis Medical Center
  • Mercy Capitol Hospital
  • CCOP - Iowa Oncology Research Association
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  • Medical Oncology and Hematology Associates at Mercy Cancer Center
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
  • John Stoddard Cancer Center at Iowa Lutheran Hospital
  • Siouxland Hematology-Oncology Associates, LLP
  • Mercy Medical Center - Sioux City
  • St. Luke's Regional Medical Center
  • Medical Oncology and Hematology Associates - West Des Moines
  • Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
  • DeCesaris Cancer Institute at Anne Arundel Medical Center
  • Tufts-NEMC Cancer Center
  • Newton-Wellesley Hospital
  • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
  • Morton Hospital & Medical Center
  • Hickman Cancer Center at Bixby Medical Center
  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
  • CCOP - Michigan Cancer Research Consortium
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
  • Green Bay Oncology, Limited - Escanaba
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Green Bay Oncology, Limited - Iron Mountain
  • Foote Hospital
  • Borgess Medical Center
  • West Michigan Cancer Center
  • Bronson Methodist Hospital
  • Haematology-Oncology Associates of Ohio and Michigan, PC
  • Sparrow Regional Cancer Center
  • Mercy Memorial Hospital System
  • Seton Cancer Institute - Saginaw
  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
  • St. John Macomb Hospital
  • Fairview Ridges Hospital
  • Mercy and Unity Cancer Center at Mercy Hospital
  • CCOP - Duluth
  • Miller-Dwan Medical Center
  • St. Mary's - Duluth Clinic Cancer Center
  • Fairview Southdale Hospital
  • Mercy and Unity Cancer Center at Unity Hospital
  • Hutchinson Area Health Care
  • Meeker County Memorial Hospital
  • HealthEast Cancer Care at St. John's Hospital
  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
  • Hennepin County Medical Center - Minneapolis
  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
  • CCOP - Metro-Minnesota
  • Saint Francis Cancer Center
  • St. Joseph's Hospital
  • CentraCare Clinic - River Campus
  • Park Nicollet Health Services
  • Regions Hospital Cancer Care Center
  • United Hospital
  • Ridgeview Medical Center
  • Woodwinds Health Campus
  • CCOP - Kansas City
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • Missouri Baptist Cancer Center
  • CCOP - Montana Cancer Consortium
  • Northern Rockies Radiation Oncology Center
  • Deaconess Billings Clinic - Downtown
  • Big Sky Oncology
  • Great Falls Clinic
  • Sletten Regional Cancer Institute at Benefis Healthcare
  • Cancer Resource Center - Lincoln
  • CCOP - Missouri Valley Cancer Consortium
  • Immanuel Medical Center
  • Alegant Health Cancer Center at Bergan Mercy Medical Center
  • Creighton University Medical Center
  • CCOP - Nevada Cancer Research Foundation
  • Veterans Affairs Medical Center - East Orange
  • Hunterdon Regional Cancer Center at Hunterdon Medical Center
  • Cancer Institute of New Jersey at Hamilton
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  • Mountainside Hospital Cancer Center
  • Carol G. Simon Cancer Center at Morristown Memorial Hospital
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Warren Hospital
  • Booker Cancer Center at Riverview Medical Center
  • Shore Memorial Hospital - Somers Point
  • Overlook Hospital
  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
  • Albert Einstein Cancer Center at Albert Einstein College of Medicine
  • Our Lady of Mercy Medical Center Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Buffalo
  • Lipson Cancer and Blood Center at Rochester General Hospital
  • CCOP - Hematology-Oncology Associates of Central New York
  • Wayne Memorial Hospital, Incorporated
  • Wilson Medical Center
  • Bismarck Cancer Center
  • Cancer Care Center at Medcenter One Hospital
  • Mid Dakota Clinic, P. C.
  • St. Alexius Medical Center
  • Akron City Hospital
  • Aultman Hospital Cancer Center at Aultman Health Foundation
  • Adena Regional Medical Center
  • MetroHealth's Cancer Care Center at MetroHealth Medical Center
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Riverside Cancer Services
  • Mount Carmel Health - West Hospital
  • Doctors Hospital at Ohio Health
  • David L. Rike Cancer Center at Miami Valley Hospital
  • Samaritan North Cancer Care Center
  • Veterans Affairs Medical Center - Dayton
  • Grady Memorial Hospital
  • Blanchard Valley Medical Associates
  • Fremont Memorial Hospital
  • Charles F. Kettering Memorial Hospital
  • Fairfield Medical Center
  • St. Rita's Medical Center
  • Lima Memorial Hospital
  • MedCentral - Mansfield Hospital
  • Strecker Cancer Center at Marietta Memorial Hospital
  • St. Luke's Hospital
  • Northwest Ohio Oncology Center
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • St. Charles Mercy Hospital
  • Firelands Regional Medical Center
  • Mercy Medical Center
  • Community Hospital of Springfield and Clark County
  • Flower Hospital Cancer Center
  • Mercy Hospital of Tiffin
  • Toledo Hospital
  • St. Vincent Mercy Medical Center
  • Medical University of Ohio Cancer Center
  • CCOP - Toledo Community Hospital
  • Toledo Clinic, Incorporated - Main Clinic
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Fulton County Health Center
  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  • Bryn Mawr Hospital
  • Geisinger Medical Center
  • Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
  • Easton Regional Cancer Center at Easton Hospital
  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Lancaster General Hospital
  • Lewistown Hospital
  • Paoli Memorial Hospital
  • Joan Karnell Cancer Center at Pennsylvania Hospital
  • Cancer Center at Phoenixville Hospital
  • Allegheny Cancer Center at Allegheny General Hospital
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
  • Pottstown Memorial Regional Cancer Center
  • Reading Hospital and Medical Center
  • Mercy Hospital Cancer Center - Scranton
  • Hematology and Oncology Associates
  • Grand View Hospital
  • Mount Nittany Medical Center
  • Jennersville Regional Hospital
  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  • CCOP - MainLine Health
  • Lankenau Cancer Center at Lankenau Hospital
  • Cancer Care Institute of Carolina at Aiken Regional Medical Centers
  • CCOP - Greenville
  • Avera Cancer Institute
  • Medical X-Ray Center, PC
  • Sioux Valley Hospital and University of South Dakota Medical Center
  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  • MBCCOP - Meharry Medical College - Nashville
  • CCOP - Scott and White Hospital
  • University of Virginia Cancer Center at UV Health System
  • Danville Regional Medical Center
  • Southwest Virginia Regional Cancer Center
  • Virginia Commonwealth University Massey Cancer Center
  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
  • Marshall University Medical Center
  • Green Bay Oncology, Limited at St. Vincent Hospital
  • Green Bay Oncology, Limited at St. Mary's Hospital
  • St. Mary's Hospital Medical Center - Green Bay
  • St. Vincent Hospital Regional Cancer Center
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  • Dean Medical Center - Madison
  • University of Wisconsin Comprehensive Cancer Center
  • Bay Area Cancer Care Center at Bay Area Medical Center
  • Marshfield Clinic - Marshfield Center
  • Green Bay Oncology, Limited - Oconto Falls
  • All Saints Cancer Center at All Saints Healthcare
  • Green Bay Oncology, Limited - Sturgeon Bay
  • Pretoria Academic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A (Paclitaxel + Carboplatin + RT)

Arm B (Paclitaxel + Carboplatin + RT+ Thalidomide)

Arm Description

Induction chemotherapy dosing: Paclitaxel, 225 mg/m² (3 hour infusion) Day 1. Carboplatin, area under the plasma drug concentration versus time curve (AUC) =6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 Concurrent chemotherapy / radiotherapy dosing: Paclitaxel, 45 mg/m2, administered weekly during radiotherapy over one hour. Carboplatin, AUC=2, 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV

paclitaxel, carboplatin, and radiotherapy are same as those in Arm A. thalidomide: Induction chemotherapy dosing, oral daily, starting Day 1 for 24 months or until disease progression. Concurrent chemotherapy / radiotherapy dosing, oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.

Outcomes

Primary Outcome Measures

Overall Survival Time
Survival time is defined as time from study entry to death from any cause

Secondary Outcome Measures

Time to Disease Progression
Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
Response Rate at Best Response to Treatment
Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.

Full Information

First Posted
March 7, 2000
Last Updated
May 29, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004859
Brief Title
Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer
Official Title
A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Trial was stopped early for futility
Study Start Date
January 2000 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.
Detailed Description
OBJECTIVES: I. Compare the survival and time to progression of patients with stage IIIA or IIIB non-small cell lung cancer when treated with carboplatin, paclitaxel, and chemoradiotherapy with or without thalidomide. II. Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two groups. III. Determine whether the inactivation of p16, Death-associated protein kinase (DAP-kinase), O6-methylguanine-DNA methyltransferase (MGMT) gene, or tissue-inhibitor of metalloproteinase 3 (TIMP-3) genes can be used to predict survival in these patients treated with this regimen. IV. Determine whether the detection of a methylation biomarker in serum can be used to predict survival in these patients treated with this regimen. OUTLINE: This is a randomized study. Patients are stratified according to disease histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and time of randomization (before addition of chemoradiotherapy vs after). Patients are randomized to one of two treatment arms. ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours immediately followed by carboplatin IV over 15-30 minutes on days 1 and 22. Treatment continues every 22 days in the absence of unacceptable toxicity or disease progression. ARM B: Patients receive paclitaxel and carboplatin as in arm A. Patients also receive oral thalidomide and oral low-dose aspirin daily beginning on day 1 for up to 24 months in the absence of disease progression. Beginning between days 43-50, patients in both arms with stable or responding disease receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30 minutes once weekly for 6 weeks and radiotherapy (RT) 5 days a week for 6 weeks. Arm B patients continue oral thalidomide. Patients are followed every 2 months for 2 years and then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
589 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Paclitaxel + Carboplatin + RT)
Arm Type
Active Comparator
Arm Description
Induction chemotherapy dosing: Paclitaxel, 225 mg/m² (3 hour infusion) Day 1. Carboplatin, area under the plasma drug concentration versus time curve (AUC) =6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 Concurrent chemotherapy / radiotherapy dosing: Paclitaxel, 45 mg/m2, administered weekly during radiotherapy over one hour. Carboplatin, AUC=2, 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV
Arm Title
Arm B (Paclitaxel + Carboplatin + RT+ Thalidomide)
Arm Type
Experimental
Arm Description
paclitaxel, carboplatin, and radiotherapy are same as those in Arm A. thalidomide: Induction chemotherapy dosing, oral daily, starting Day 1 for 24 months or until disease progression. Concurrent chemotherapy / radiotherapy dosing, oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
CBDCA, Paraplatin, JM-8, NSC 241240
Intervention Description
Induction Chemotherapy dosing: AUC=6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing, AUC=2; 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Taxol, NSC 125973
Intervention Description
Induction chemotherapy dosing: 225 mg/m² (3 hour infusion) Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing: 45 mg/m2; administered weekly during radiotherapy over one hour
Intervention Type
Drug
Intervention Name(s)
thalidomide
Other Intervention Name(s)
(d,1)-N phthalidoglutarimide, Thalomid, NSC #66847, IND # 48832
Intervention Description
Induction Chemotherapy dosing: oral daily, starting Day 1 for 24 months or until disease progression. Concurrent Chemotherapy / Radiotherapy dosing: oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
thoracic radiotherapy
Intervention Description
Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV
Primary Outcome Measure Information:
Title
Overall Survival Time
Description
Survival time is defined as time from study entry to death from any cause
Time Frame
every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5
Secondary Outcome Measure Information:
Title
Time to Disease Progression
Description
Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
Time Frame
every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year
Title
Response Rate at Best Response to Treatment
Description
Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.
Time Frame
every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma Squamous cell Adenocarcinoma Large cell undifferentiated Bronchoalveolar Non-small cell carcinoma not otherwise stated Unresectable stage IIIA Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule out resectability OR Stage IIIB disease without significant pleural effusion Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1 thoracentesis and is cytologically negative Metastases to contralateral, mediastinal, or supraclavicular nodes allowed Bidimensionally measurable or evaluable disease 18 and over ECOG performance status 0-1 Adequate hematopoietic, hepatic, and renal function obtained <=4 weeks prior to registration: Platelet count at least 100,000/mm^3 White Blood Cell (WBC) count at least 4,000/mm^3 OR absolute neutrophil count at least 2,000/mm^3 Bilirubin normal Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper limit of normal Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy Concurrent filgrastim (G-CSF) allowed for persistent neutropenia Exclusion Criteria: Positive pregnancy test,pregnant or nursing Uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year Serious cardiac arrhythmias requiring medication Prior radiotherapy to only area of measurable or active tumor Less than 5 years since prior chemotherapy Other active malignancies Serious uncontrolled active infection Evidence of greater than grade 1 neuropathy by history or physical examination History of seizure disorders Contraindication to daily low-dose (81 mg/day) aspirin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan H. Schiller, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
City
Ft. Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
Facility Name
Memorial Medical Center Cancer Services
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
Salinas Valley Memorial Hospital
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
Stanford Comprehensive Cancer Center at Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Aurora Presbyterian Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-9019
Country
United States
Facility Name
Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Penrose Cancer Center at Penrose Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80933
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
St. Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program, Incorporated
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224-2522
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81502
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Hope Cancer Care Center at Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80502
Country
United States
Facility Name
St. Mary-Corwin Regional Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
North Suburban Medical Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Praxair Cancer Center at Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
William W. Backus Hospital
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Halifax Medical Center - Daytona Beach
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32115
Country
United States
Facility Name
Baptist Cancer Institute - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Veterans Affairs Medical Center - Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
Facility Name
MBCCOP - Medical College of Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Veterans Affairs Medical Center - Atlanta (Decatur)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Medical Center of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31208
Country
United States
Facility Name
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403-3089
Country
United States
Facility Name
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
City
Valdosta
State/Province
Georgia
ZIP/Postal Code
31603
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Mercy Hospital and Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Swedish Covenant Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Name
Hinsdale Hematology Oncology Associates
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Midwest Center for Hematology/Oncology
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60432
Country
United States
Facility Name
Trinity Medical Center - East
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Swedish-American Regional Cancer Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104-2315
Country
United States
Facility Name
Hematology/Oncology of the North Shore at Gross Point Medical Center
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Howard Community Hospital at Howard Regional Health System
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Reid Hospital & Health Care Services, Incorporated
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Hematology Oncology Associates of the Quad Cities
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
St. Luke's Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52402
Country
United States
Facility Name
Cedar Rapids Oncology Associates
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Genesis Regional Cancer Center at Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Mercy Capitol Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50307
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at Mercy Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316-2301
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Medical Oncology and Hematology Associates - West Des Moines
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
DeCesaris Cancer Institute at Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Tufts-NEMC Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Morton Hospital & Medical Center
City
Taunton
State/Province
Massachusetts
ZIP/Postal Code
02780
Country
United States
Facility Name
Hickman Cancer Center at Bixby Medical Center
City
Adrian
State/Province
Michigan
ZIP/Postal Code
49221
Country
United States
Facility Name
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123-2500
Country
United States
Facility Name
Green Bay Oncology, Limited - Escanaba
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49431
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Green Bay Oncology, Limited - Iron Mountain
City
Iron Mountain
State/Province
Michigan
ZIP/Postal Code
49801
Country
United States
Facility Name
Foote Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazooaa
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Haematology-Oncology Associates of Ohio and Michigan, PC
City
Lambertville
State/Province
Michigan
ZIP/Postal Code
48144
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48909
Country
United States
Facility Name
Mercy Memorial Hospital System
City
Monroe
State/Province
Michigan
ZIP/Postal Code
48162
Country
United States
Facility Name
Seton Cancer Institute - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy and Unity Cancer Center at Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Miller-Dwan Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
St. Mary's - Duluth Clinic Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
City
Fergus Falls
State/Province
Minnesota
ZIP/Postal Code
56537
Country
United States
Facility Name
Mercy and Unity Cancer Center at Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Hutchinson Area Health Care
City
Hutchinson
State/Province
Minnesota
ZIP/Postal Code
55350
Country
United States
Facility Name
Meeker County Memorial Hospital
City
Lichfield
State/Province
Minnesota
ZIP/Postal Code
55355
Country
United States
Facility Name
HealthEast Cancer Care at St. John's Hospital
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422-2900
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Saint Francis Cancer Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
St. Joseph's Hospital
City
St Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
CentraCare Clinic - River Campus
City
St. Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Park Nicollet Health Services
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital Cancer Care Center
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Woodwinds Health Campus
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Deaconess Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Big Sky Oncology
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Regional Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Cancer Resource Center - Lincoln
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Immanuel Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68122
Country
United States
Facility Name
Alegant Health Cancer Center at Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-2197
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Veterans Affairs Medical Center - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018-1095
Country
United States
Facility Name
Hunterdon Regional Cancer Center at Hunterdon Medical Center
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Cancer Institute of New Jersey at Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Mountainside Hospital Cancer Center
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
Facility Name
Carol G. Simon Cancer Center at Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Warren Hospital
City
Phillipsburg
State/Province
New Jersey
ZIP/Postal Code
08865
Country
United States
Facility Name
Booker Cancer Center at Riverview Medical Center
City
Red Bank
State/Province
New Jersey
ZIP/Postal Code
07701
Country
United States
Facility Name
Shore Memorial Hospital - Somers Point
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Albert Einstein Cancer Center at Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Our Lady of Mercy Medical Center Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Veterans Affairs Medical Center - Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Lipson Cancer and Blood Center at Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
CCOP - Hematology-Oncology Associates of Central New York
City
Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wilson Medical Center
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893-3428
Country
United States
Facility Name
Bismarck Cancer Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Cancer Care Center at Medcenter One Hospital
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Mid Dakota Clinic, P. C.
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
St. Alexius Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58502
Country
United States
Facility Name
Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Aultman Hospital Cancer Center at Aultman Health Foundation
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710-1799
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
MetroHealth's Cancer Care Center at MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Riverside Cancer Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel Health - West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Veterans Affairs Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Blanchard Valley Medical Associates
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Fremont Memorial Hospital
City
Fremont
State/Province
Ohio
ZIP/Postal Code
43420
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
St. Rita's Medical Center
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Lima Memorial Hospital
City
Lima
State/Province
Ohio
ZIP/Postal Code
45804
Country
United States
Facility Name
MedCentral - Mansfield Hospital
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44903
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
St. Luke's Hospital
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Northwest Ohio Oncology Center
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
St. Charles Mercy Hospital
City
Oregon
State/Province
Ohio
ZIP/Postal Code
43616
Country
United States
Facility Name
Firelands Regional Medical Center
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Mercy Medical Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Flower Hospital Cancer Center
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Mercy Hospital of Tiffin
City
Tiffin
State/Province
Ohio
ZIP/Postal Code
44883
Country
United States
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
St. Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Medical University of Ohio Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
CCOP - Toledo Community Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Toledo Clinic, Incorporated - Main Clinic
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373-1300
Country
United States
Facility Name
Fulton County Health Center
City
Wauseon
State/Province
Ohio
ZIP/Postal Code
43567
Country
United States
Facility Name
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
City
Dubois
State/Province
Pennsylvania
ZIP/Postal Code
15801
Country
United States
Facility Name
Easton Regional Cancer Center at Easton Hospital
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18042
Country
United States
Facility Name
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17105
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Lewistown Hospital
City
Lewistown
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
Facility Name
Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
Joan Karnell Cancer Center at Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Cancer Center at Phoenixville Hospital
City
Phoenixville
State/Province
Pennsylvania
ZIP/Postal Code
19460
Country
United States
Facility Name
Allegheny Cancer Center at Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Pottstown Memorial Regional Cancer Center
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612-6052
Country
United States
Facility Name
Mercy Hospital Cancer Center - Scranton
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18501
Country
United States
Facility Name
Hematology and Oncology Associates
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
Facility Name
Grand View Hospital
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
Mount Nittany Medical Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Facility Name
Jennersville Regional Hospital
City
West Grove
State/Province
Pennsylvania
ZIP/Postal Code
19390-9499
Country
United States
Facility Name
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Cancer Care Institute of Carolina at Aiken Regional Medical Centers
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29801
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Medical X-Ray Center, PC
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sioux Valley Hospital and University of South Dakota Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37662
Country
United States
Facility Name
MBCCOP - Meharry Medical College - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208-3599
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Virginia Cancer Center at UV Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Southwest Virginia Regional Cancer Center
City
Norton
State/Province
Virginia
ZIP/Postal Code
24273
Country
United States
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Marshall University Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Mary's Hospital Medical Center - Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Dean Medical Center - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Bay Area Cancer Care Center at Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Green Bay Oncology, Limited - Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
All Saints Cancer Center at All Saints Healthcare
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States
Facility Name
Green Bay Oncology, Limited - Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235
Country
United States
Facility Name
Pretoria Academic Hospital
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
17406356
Citation
Belinsky SA, Grimes MJ, Casas E, Stidley CA, Franklin WA, Bocklage TJ, Johnson DH, Schiller JH. Predicting gene promoter methylation in non-small-cell lung cancer by evaluating sputum and serum. Br J Cancer. 2007 Apr 23;96(8):1278-83. doi: 10.1038/sj.bjc.6603721. Epub 2007 Apr 3.
Results Reference
result
Citation
Belinsky SA, Grimes M, Johnson D, et al.: Predicting gene promoter methylation in lung tumors through examination of sputum and serum. [Abstract] J Clin Oncol 24 (Suppl 18): A-7208, 416s, 2006.
Results Reference
result

Learn more about this trial

Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer

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