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Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Induction Carboplatin
Induction Paclitaxel
Resection
Consolidation Carboplatin
Radiation Therapy
Consolidation Paclitaxel
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

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

Inclusion Criteria: Patients with Stage IIIA (T1-3 N2) or Stage IIIB (N3, excluding supraclavicular involvement) non-small cell lung cancer documented by biopsy or cytology (Pancoast tumors are eligible if pathologic evidence of mediastinal nodal disease is present); Disease must be measurable; Mediastinal lymph nodes must be proven positive by pathologic review. All patients must undergo mediastinoscopy, thoracoscopy, Chamberlain procedure, or transbronchial needle aspirate to evaluate extent of nodal involvement. Any lymph node assessed by mediastinoscopy and found to be positive will be defined as N2 disease; Patients ≥ 18 years of age; Life expectancy ≥ 6 months; Zubrod performance status 0- 1 (See Appendix II); Pretreatment laboratory values must be as follows: White blood cell count (WBC) count: ≥ 3,000/mm^3; Absolute granulocyte count: ≥ 1,500/mm^3; Platelets: ≥ 100,000/mm3; Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN); Serum creatinine: ≤ 1.5 x institutional ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x institutional ULN; serum albumin: ≥ 3.0 g/dL Baseline forced expiratory volume (FEV1) must be at least 2.0 liters; if less than 2.0 then V/Q scan is required and projected post-operative FEV1 must be > 800 cc based on the following formula using the quantitative Ventilation/perfusion (V/Q) scan: FEV1 = FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report. Patient evaluation and acceptance by thoracic surgery, medical oncology, and radiation oncology; patient must be a potential surgical candidate prior to the initiation of therapy; Women of childbearing potential and male participants must practice an effective method of contraception during the study; Pretreatment evaluations required for eligibility include: A complete medical history & physical examination to include Zubrod performance status, neurologic assessment, recent weight loss, usual weight, concurrent non-malignant disease and therapy; Location, type, and size of measurable lesion must be recorded prior to treatment; Complete blood count (CBC) with differential, platelet count, electrolytes, and Mg++ within 14 days prior to study entry; Twelve-channel serum multiple analysis (SMA-12): Total protein, Albumin, Calcium, Glucose, Blood urea nitrogen (BUN), Creatinine, Alkaline Phosphatase, Lactate dehydrogenase (LDH), Total Bilirubin, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) within 14 days prior to study entry; Women of childbearing potential must have a negative pre-study serum or urine pregnancy test within 14 days prior to study entry. Mediastinoscopy, thoracoscopy, Chamberlain procedure, or bronchoscopy with transbronchial needle aspirate to evaluate the extent of lymph node involvement; Computed tomography (CT) scan of the chest to include liver, and adrenal glands within 6 weeks prior to study entry; Positron emission tomography (PET) scan within 8 weeks prior to study entry. Any suspicious areas outside of the local regional disease requires documented evaluation of these findings to exclude metastatic disease; CT scan or magnetic resonance imaging (MRI) of the brain within 6 weeks prior to study entry; Electrocardiogram (EKG) and pulmonary function tests including forced vital capacity (FVC), FEV-1, and diffusing capacity of carbon monoxide (DLCO), within 8 weeks prior to study entry; V/Q scan, if applicable, within 8 weeks prior to study entry. Patients must sign a study-specific informed consent prior to study entry. Exclusion Criteria: Small cell lung cancer; distant metastatic disease; Evidence of clinical or radiographic supraclavicular lymph node involvement; Bronchioalveolar carcinoma with lobar or multilobar involvement; Unintentional weight loss > 5% within 6 months prior to study entry, or Zubrod performance status 2 or greater; Primary tumor location prevents delivery of 60 Gy and simultaneously limiting spinal cord dose to 48 Gy; Patients with malignant pleural effusion; Clinically evident superior vena cava syndrome; Prior systemic chemotherapy or radiation therapy to the thorax; Patients with known hypersensitivity to Cremophor EL; Patients receiving other investigational therapy; Pregnant or lactating women are ineligible, as treatment involves unforeseeable risks to the participant and to the embryo or fetus; Patients with an active serious infection or other serious underlying medical condition that would impair their ability to complete protocol treatment; Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.

Sites / Locations

  • Arizona Oncology Services Foundation
  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Mayo Clinic - Jacksonville
  • Tallahassee Memorial Hospital
  • Cancer Institute at St. John's Hospital
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Saint Joseph Mercy Cancer Center
  • CCOP - Michigan Cancer Research Consortium
  • Mayo Clinic Cancer Center
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • Methodist Estabrook Cancer Center
  • Cancer Institute of New Jersey at Cooper University Hospital - Camden
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • Leo W. Jenkins Cancer Center at ECU Medical School
  • St. Luke's Cancer Network at St. Luke's Hospital
  • Hollings Cancer Center at Medical University of South Carolina
  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  • Schiffler Cancer Center at Wheeling Hospital
  • St. Vincent Hospital Regional Cancer Center
  • Medical College of Wisconsin Cancer Center
  • Veterans Affairs Medical Center - Milwaukee

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemoradiation, Surgery, Chemotherapy

Arm Description

Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.

Outcomes

Primary Outcome Measures

Mediastinal Nodal Clearance Rate
If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error.

Secondary Outcome Measures

Percentage of Patients With Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy
Complete pathologic response is defined as complete resection achieved and no evidence of viable tumor in the entire resection specimen.
Percentage of Patients With Major Surgical Morbidities Within 30 Days of Surgery
The surgical morbidities occurring within 30 days following resection were assessed and graded using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. A major morbidity is considered a grade 3 or higher of any of the following: pneumonitis, infection, atelectasis, chest tube drainage/bronchial stump leak, pneumothorax, chylothorax, cardiac ischemia/infarction, pulmonary thrombosis/embolism, supraventricular atrial arrhythmia, ventricular arrhythmia, post-operative hemorrhage, pulmonary/upper respiratory fistula, pleural effusion, or death.
Percentage of Patients Able to Undergo Surgical Resection
Distribution of R0, R1, and R2 Resections After Chemotherapy
An R0 resection is defined as a complete resection of all disease with negative margins and the highest lymph node resected negative for residual tumor. An R1 resection is defined as a complete resection of all disease with pathology of positive margins, pathologic evidence of tumor cells in the highest lymph node resected in the mediastinum, or extracapsular nodal spread. An R2 resection is defined as gross residual disease left behind after surgical resection.
Overall Survival at Two Years
Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rate is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Progression-free Survival at Two Years
Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. An event for progression-free survival is the first occurrence of progression or death due to any cause. Progression-free survival time is defined as the time from study entry to the the date progression or death, or last known follow-up (censored) if neither progression nor death occurred. Progression-free survival rate is estimated using the Kaplan-Meier method.
Distribution of Highest Grade Adverse Event
The number of patients whose highest grade adverse event (AE) reported was 3, 4, or 5 was calculated. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Number of patients with highest grade of 3, 4, and 5 are presented.

Full Information

First Posted
November 9, 2004
Last Updated
September 4, 2019
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00096226
Brief Title
Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
Official Title
A Phase II Trial Of Neoadjuvant Therapy With Concurrent Chemotherapy And High Dose Radiotherapy Followed By Surgical Resection And Consolidative Therapy For Locally Advanced Non-Small Cell Lung Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving paclitaxel and carboplatin together with radiation therapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any tumor cells remaining after surgery. PURPOSE: This phase II trial is studying how well giving paclitaxel and carboplatin together with radiation therapy works in treating patients who are undergoing surgery for stage III non-small cell lung cancer.
Detailed Description
OBJECTIVES: Determine the mediastinal node clearance rate in patients with stage IIIA or IIIB non-small cell lung cancer treated with neoadjuvant induction chemoradiotherapy comprising paclitaxel, carboplatin, and high-dose radiotherapy followed by surgical resection for patients found to be resectable and consolidative chemotherapy comprising paclitaxel and carboplatin. Determine the rate of complete pathological response in patients treated with this regimen. Determine the feasibility of surgical resection after neoadjuvant induction chemoradiotherapy in these patients. Determine disease-free and overall survival of patients treated with this regimen. Determine the toxicity of this regimen in these patients.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemoradiation, Surgery, Chemotherapy
Arm Type
Experimental
Arm Description
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
Intervention Type
Drug
Intervention Name(s)
Induction Carboplatin
Intervention Type
Drug
Intervention Name(s)
Induction Paclitaxel
Intervention Type
Procedure
Intervention Name(s)
Resection
Intervention Type
Drug
Intervention Name(s)
Consolidation Carboplatin
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Type
Drug
Intervention Name(s)
Consolidation Paclitaxel
Primary Outcome Measure Information:
Title
Mediastinal Nodal Clearance Rate
Description
If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error.
Time Frame
At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.
Secondary Outcome Measure Information:
Title
Percentage of Patients With Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy
Description
Complete pathologic response is defined as complete resection achieved and no evidence of viable tumor in the entire resection specimen.
Time Frame
At time of surgery (16-18 weeks)
Title
Percentage of Patients With Major Surgical Morbidities Within 30 Days of Surgery
Description
The surgical morbidities occurring within 30 days following resection were assessed and graded using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. A major morbidity is considered a grade 3 or higher of any of the following: pneumonitis, infection, atelectasis, chest tube drainage/bronchial stump leak, pneumothorax, chylothorax, cardiac ischemia/infarction, pulmonary thrombosis/embolism, supraventricular atrial arrhythmia, ventricular arrhythmia, post-operative hemorrhage, pulmonary/upper respiratory fistula, pleural effusion, or death.
Time Frame
From 0 to 30 days following surgery (surgery occurs within 16-18 weeks after registration)
Title
Percentage of Patients Able to Undergo Surgical Resection
Time Frame
At time of surgery (16-18 weeks)
Title
Distribution of R0, R1, and R2 Resections After Chemotherapy
Description
An R0 resection is defined as a complete resection of all disease with negative margins and the highest lymph node resected negative for residual tumor. An R1 resection is defined as a complete resection of all disease with pathology of positive margins, pathologic evidence of tumor cells in the highest lymph node resected in the mediastinum, or extracapsular nodal spread. An R2 resection is defined as gross residual disease left behind after surgical resection.
Time Frame
At time of surgery (16-18 weeks)
Title
Overall Survival at Two Years
Description
Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rate is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Time Frame
From registration to two years
Title
Progression-free Survival at Two Years
Description
Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. An event for progression-free survival is the first occurrence of progression or death due to any cause. Progression-free survival time is defined as the time from study entry to the the date progression or death, or last known follow-up (censored) if neither progression nor death occurred. Progression-free survival rate is estimated using the Kaplan-Meier method.
Time Frame
From registration to two years
Title
Distribution of Highest Grade Adverse Event
Description
The number of patients whose highest grade adverse event (AE) reported was 3, 4, or 5 was calculated. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Number of patients with highest grade of 3, 4, and 5 are presented.
Time Frame
From start of treatment to end of follow-up, a maximum of 64.3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Stage IIIA (T1-3 N2) or Stage IIIB (N3, excluding supraclavicular involvement) non-small cell lung cancer documented by biopsy or cytology (Pancoast tumors are eligible if pathologic evidence of mediastinal nodal disease is present); Disease must be measurable; Mediastinal lymph nodes must be proven positive by pathologic review. All patients must undergo mediastinoscopy, thoracoscopy, Chamberlain procedure, or transbronchial needle aspirate to evaluate extent of nodal involvement. Any lymph node assessed by mediastinoscopy and found to be positive will be defined as N2 disease; Patients ≥ 18 years of age; Life expectancy ≥ 6 months; Zubrod performance status 0- 1 (See Appendix II); Pretreatment laboratory values must be as follows: White blood cell count (WBC) count: ≥ 3,000/mm^3; Absolute granulocyte count: ≥ 1,500/mm^3; Platelets: ≥ 100,000/mm3; Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN); Serum creatinine: ≤ 1.5 x institutional ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x institutional ULN; serum albumin: ≥ 3.0 g/dL Baseline forced expiratory volume (FEV1) must be at least 2.0 liters; if less than 2.0 then V/Q scan is required and projected post-operative FEV1 must be > 800 cc based on the following formula using the quantitative Ventilation/perfusion (V/Q) scan: FEV1 = FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report. Patient evaluation and acceptance by thoracic surgery, medical oncology, and radiation oncology; patient must be a potential surgical candidate prior to the initiation of therapy; Women of childbearing potential and male participants must practice an effective method of contraception during the study; Pretreatment evaluations required for eligibility include: A complete medical history & physical examination to include Zubrod performance status, neurologic assessment, recent weight loss, usual weight, concurrent non-malignant disease and therapy; Location, type, and size of measurable lesion must be recorded prior to treatment; Complete blood count (CBC) with differential, platelet count, electrolytes, and Mg++ within 14 days prior to study entry; Twelve-channel serum multiple analysis (SMA-12): Total protein, Albumin, Calcium, Glucose, Blood urea nitrogen (BUN), Creatinine, Alkaline Phosphatase, Lactate dehydrogenase (LDH), Total Bilirubin, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) within 14 days prior to study entry; Women of childbearing potential must have a negative pre-study serum or urine pregnancy test within 14 days prior to study entry. Mediastinoscopy, thoracoscopy, Chamberlain procedure, or bronchoscopy with transbronchial needle aspirate to evaluate the extent of lymph node involvement; Computed tomography (CT) scan of the chest to include liver, and adrenal glands within 6 weeks prior to study entry; Positron emission tomography (PET) scan within 8 weeks prior to study entry. Any suspicious areas outside of the local regional disease requires documented evaluation of these findings to exclude metastatic disease; CT scan or magnetic resonance imaging (MRI) of the brain within 6 weeks prior to study entry; Electrocardiogram (EKG) and pulmonary function tests including forced vital capacity (FVC), FEV-1, and diffusing capacity of carbon monoxide (DLCO), within 8 weeks prior to study entry; V/Q scan, if applicable, within 8 weeks prior to study entry. Patients must sign a study-specific informed consent prior to study entry. Exclusion Criteria: Small cell lung cancer; distant metastatic disease; Evidence of clinical or radiographic supraclavicular lymph node involvement; Bronchioalveolar carcinoma with lobar or multilobar involvement; Unintentional weight loss > 5% within 6 months prior to study entry, or Zubrod performance status 2 or greater; Primary tumor location prevents delivery of 60 Gy and simultaneously limiting spinal cord dose to 48 Gy; Patients with malignant pleural effusion; Clinically evident superior vena cava syndrome; Prior systemic chemotherapy or radiation therapy to the thorax; Patients with known hypersensitivity to Cremophor EL; Patients receiving other investigational therapy; Pregnant or lactating women are ineligible, as treatment involves unforeseeable risks to the participant and to the embryo or fetus; Patients with an active serious infection or other serious underlying medical condition that would impair their ability to complete protocol treatment; Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohan Suntharalingam, MD
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Oncology Services Foundation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Cancer Institute at St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Saint Joseph Mercy Cancer Center
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
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Methodist Estabrook Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper University Hospital - Camden
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Leo W. Jenkins Cancer Center at ECU Medical School
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27835-6028
Country
United States
Facility Name
St. Luke's Cancer Network at St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
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
Schiffler Cancer Center at Wheeling Hospital
City
Wheeling
State/Province
West Virginia
ZIP/Postal Code
26003
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
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22543206
Citation
Suntharalingam M, Paulus R, Edelman MJ, Krasna M, Burrows W, Gore E, Wilson LD, Choy H. Radiation therapy oncology group protocol 02-29: a phase II trial of neoadjuvant therapy with concurrent chemotherapy and full-dose radiation therapy followed by surgical resection and consolidative therapy for locally advanced non-small cell carcinoma of the lung. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):456-63. doi: 10.1016/j.ijrobp.2011.11.069. Epub 2012 Apr 28.
Results Reference
result
Citation
Suntharalingam M, Paulus R, Edelman MJ, et al.: RTOG 0229: A phase II trial of neoadjuvant therapy with concurrent chemotherapy and high-dose radiotherapy (XRT) followed by resection and consolidative therapy for LA-NSCLC. [Abstract] J Clin Oncol 28 (Suppl 15): A-7024, 2010.
Results Reference
result

Learn more about this trial

Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer

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