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Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
filgrastim
cisplatin
docetaxel
fluorouracil
paclitaxel
radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx, recurrent metastatic squamous neck cancer with occult primary, recurrent lymphoepithelioma of the oropharynx

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically* or cytologically* confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic variants: Spindle cell carcinoma Poorly differentiated keratin-positive carcinoma Lymphoepithelioma NOTE: *Biopsy or primary tumor and/or fine needle aspiration of the metastatic lymph node required Original or second primary tumor Recurrent neck metastases with unknown primary allowed Locally recurrent disease Measurable disease Unresectable disease Attempted surgical resection allowed provided surgery was performed ≥ 3 months ago, wound is completely healed, and there is no sign of carotid exposure Must have had prior radiotherapy for SCC of the head and neck with > 75% of the present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy Able to successfully re-irradiate the area of the gross tumor volume without exceeding lifetime spinal cord dose of 54 Gy as determined by physical examination and CT scan and/or MRI performed within the past 8 weeks First recurrence occurred > 6 months after completion of radiotherapy More than 1 recurrence allowed provided the above criteria for first recurrence has been met No primary tumor of the nasopharynx or salivary gland No distant metastases by history or physical examination, chest CT scan, and CT scan or MRI of the tumor site Patients with equivocal pulmonary nodules are eligible provided the nodules are < 1 cm, can be safely biopsied, or are negative by positron emission tomography imaging No circumferential tumor involvement of the carotid sheath by imaging unless prophylactic carotid stent is placed PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,800/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) Hepatic AST or ALT < 2 times upper limit of normal (ULN) Bilirubin < 1.5 mg/dL No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Renal Creatinine clearance > 50 mL/min Calcium < 11.5 mg/dL Cardiovascular No New York Heart Association class III or IV heart disease No other symptomatic or uncontrolled cardiac disease Pulmonary No chronic obstructive pulmonary disease exacerbation No other respiratory illness requiring hospitalization within the past 6 months or that would preclude study therapy Immunologic No AIDS No prior allergic reaction to E. coli-derived products No acute bacterial or fungal infection requiring IV antibiotics Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 30 days after completion of study treatment No other invasive malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the breast, oral cavity, or cervix No pre-existing peripheral sensory neuropathy > grade 2 No other severe active co-morbidity PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 6 months since prior chemotherapy No prior systemic chemotherapy for recurrent SCC of the head and neck Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for initial SCC of the head and neck allowed Endocrine therapy Not specified Radiotherapy See Disease Characteristics See Chemotherapy At least 6 months since prior radiotherapy Surgery See Disease Characteristics Other Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or other targeted agents No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and neck No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Mobile Infirmary Medical Center
  • St. Joseph's Mercy Cancer Center
  • Auburn Radiation Oncology
  • Radiation Oncology Centers - Cameron Park
  • Mercy Cancer Center at Mercy San Juan Medical Center
  • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
  • Radiation Oncology Center - Roseville
  • Radiological Associates of Sacramento Medical Group, Incorporated
  • University of California Davis Cancer Center
  • Mercy General Hospital
  • Solano Radiation Oncology Center
  • Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  • University of Florida Shands Cancer Center
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  • CCOP - Mount Sinai Medical Center
  • University of Miami Sylvester Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • MBCCOP - Medical College of Georgia Cancer Center
  • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
  • Saint Anthony's Hospital at Saint Anthony's Health Center
  • Rush-Copley Cancer Care Center
  • Joliet Oncology-Hematology Associates, Limited - West
  • Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
  • Cancer Institute at St. John's Hospital
  • Carle Cancer Center at Carle Foundation Hospital
  • CCOP - Carle Cancer Center
  • St. John's Cancer Center at St. John's Medical Center
  • St. Francis Hospital and Health Centers - Beech Grove Campus
  • Elkhart General Hospital
  • Indiana University Cancer Center
  • Howard Community Hospital at Howard Regional Health System
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • Saint Anthony Memorial Health Centers
  • Reid Hospital & Health Care Services, Incorporated
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
  • MaineGeneral Medical Center - Waterville Campus
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Hickman Cancer Center at Bixby Medical Center
  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute
  • Breslin Cancer Center at Ingham Regional Medical Center
  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
  • Saint Francis Medical Center
  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  • David C. Pratt Cancer Center at St. John's Mercy
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • CCOP - St. Louis-Cape Girardeau
  • CCOP - Montana Cancer Consortium
  • Northern Rockies Radiation Oncology Center
  • Deaconess Billings Clinic - Downtown
  • Methodist Cancer Center at Methodist Hospital - Omaha
  • CCOP - Nevada Cancer Research Foundation
  • Kingsbury Center for Cancer Care at Cheshire Medical Center
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  • J. Phillip Citta Regional Cancer Center at Community Medical Center
  • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
  • Long Island College Hospital
  • Roswell Park Cancer Institute
  • CCOP - North Shore University Hospital
  • Don Monti Comprehensive Cancer Center at North Shore University Hospital
  • Long Island Jewish Medical Center
  • Lenoir Memorial Cancer Center
  • Rutherford Hospital
  • Bismarck Cancer Center
  • Cancer Care Center at Medcenter One Hospital
  • Mid Dakota Clinic, PC
  • St. Alexius Medical Center
  • McDowell Cancer Center at Akron General Medical Center
  • Akron City Hospital
  • Grandview Hospital
  • Good Samaritan Hospital
  • David L. Rike Cancer Center at Miami Valley Hospital
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • Blanchard Valley Medical Associates
  • Charles F. Kettering Memorial Hospital
  • Lima Memorial Hospital
  • Northwest Ohio Oncology Center
  • Middletown Regional Hospital
  • St. Charles Mercy Hospital
  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
  • Firelands Regional Medical Center
  • Flower Hospital Cancer Center
  • 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
  • Cancer Treatment Center
  • United States Air Force Medical Center - Wright-Patterson
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Mercy Fitzgerald Hospital
  • Alle-Kiski Medical Center
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center - Philadelphia
  • Albert Einstein Cancer Center
  • Allegheny Cancer Center at Allegheny General Hospital
  • AnMed Health Cancer Center
  • Hollings Cancer Center at Medical University of South Carolina
  • CCOP - Upstate Carolina
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • Rapid City Regional Hospital
  • Medical X-Ray Center, PC
  • Sioux Valley Hospital and University of South Dakota Medical Center
  • Cottonwood Hospital Medical Center
  • McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center - Provo
  • Dixie Regional Medical Center - East Campus
  • Utah Cancer Specialists at UCS Cancer Center
  • Latter Day Saints Hospital
  • Norris Cotton Cancer Center - North
  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
  • University of Wisconsin Comprehensive Cancer Center
  • Community Memorial Hospital Cancer Care Center
  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
  • Medical College of Wisconsin Cancer Center
  • All Saints Cancer Center at Wheaton Franciscan Healthcare
  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital
  • West Allis Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Radiotherapy and chemotherapy

Chemotherapy

Arm Description

Radiotherapy/paclitaxel/cisplatin/filgrastim

Cisplatin/fluorouracil/paclitaxel/docetaxel

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Full Information

First Posted
June 7, 2005
Last Updated
June 26, 2013
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00113399
Brief Title
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
Official Title
A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Terminated early due to low accrual.
Study Start Date
April 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
undefined (undefined)

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: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and giving them with radiation therapy may kill more tumor cells. It is not yet known whether giving radiation therapy together with combination chemotherapy is more effective than giving combination chemotherapy alone in treating head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES: Primary Compare overall survival of patients with previously irradiated unresectable locally recurrent squamous cell carcinoma of the head and neck treated with radiotherapy, cisplatin, and paclitaxel vs cisplatin-based chemotherapy alone. Secondary Compare progression-free survival of patients treated with these regimens. Compare the toxicity of these regimens in these patients. Compare quality of life, functional/performance status, and quality-adjusted survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo radiotherapy twice daily and receive paclitaxel IV over 1 hour and cisplatin IV over 30 minutes once daily on days 1-5, 15-19, 29-33, and 43-47. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 6-13, 20-27, 34-41, and 48-55. Arm II: Patients receive 1 of the following cisplatin-based* regimens at the discretion of the treating physician: Regimen 1: Patients receive cisplatin* IV over 1-2 hours on day 1 and fluorouracil IV continuously over 96 hours on days 1-4. Regimen 2: Patients receive cisplatin* IV over 1-2 hours and paclitaxel IV over 3 hours on day 1. Regimen 3: Patients receive cisplatin* IV over 1-2 hours and docetaxel IV over 1 hour on day 1. NOTE: *Carboplatin may be substituted for cisplatin in patients with creatinine clearance < 50 mL/min or in patients who experience grade 2 or 3 neurotoxicity. For all regimens, treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond documentation of CR. Quality of life is assessed at baseline and then at 3, 6, 12, 24, and 36 months. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study within 5½ years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx, recurrent metastatic squamous neck cancer with occult primary, recurrent lymphoepithelioma of the oropharynx

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy and chemotherapy
Arm Type
Other
Arm Description
Radiotherapy/paclitaxel/cisplatin/filgrastim
Arm Title
Chemotherapy
Arm Type
Other
Arm Description
Cisplatin/fluorouracil/paclitaxel/docetaxel
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
Date of death or last follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically* or cytologically* confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic variants: Spindle cell carcinoma Poorly differentiated keratin-positive carcinoma Lymphoepithelioma NOTE: *Biopsy or primary tumor and/or fine needle aspiration of the metastatic lymph node required Original or second primary tumor Recurrent neck metastases with unknown primary allowed Locally recurrent disease Measurable disease Unresectable disease Attempted surgical resection allowed provided surgery was performed ≥ 3 months ago, wound is completely healed, and there is no sign of carotid exposure Must have had prior radiotherapy for SCC of the head and neck with > 75% of the present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy Able to successfully re-irradiate the area of the gross tumor volume without exceeding lifetime spinal cord dose of 54 Gy as determined by physical examination and CT scan and/or MRI performed within the past 8 weeks First recurrence occurred > 6 months after completion of radiotherapy More than 1 recurrence allowed provided the above criteria for first recurrence has been met No primary tumor of the nasopharynx or salivary gland No distant metastases by history or physical examination, chest CT scan, and CT scan or MRI of the tumor site Patients with equivocal pulmonary nodules are eligible provided the nodules are < 1 cm, can be safely biopsied, or are negative by positron emission tomography imaging No circumferential tumor involvement of the carotid sheath by imaging unless prophylactic carotid stent is placed PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,800/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) Hepatic AST or ALT < 2 times upper limit of normal (ULN) Bilirubin < 1.5 mg/dL No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Renal Creatinine clearance > 50 mL/min Calcium < 11.5 mg/dL Cardiovascular No New York Heart Association class III or IV heart disease No other symptomatic or uncontrolled cardiac disease Pulmonary No chronic obstructive pulmonary disease exacerbation No other respiratory illness requiring hospitalization within the past 6 months or that would preclude study therapy Immunologic No AIDS No prior allergic reaction to E. coli-derived products No acute bacterial or fungal infection requiring IV antibiotics Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 30 days after completion of study treatment No other invasive malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the breast, oral cavity, or cervix No pre-existing peripheral sensory neuropathy > grade 2 No other severe active co-morbidity PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 6 months since prior chemotherapy No prior systemic chemotherapy for recurrent SCC of the head and neck Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for initial SCC of the head and neck allowed Endocrine therapy Not specified Radiotherapy See Disease Characteristics See Chemotherapy At least 6 months since prior radiotherapy Surgery See Disease Characteristics Other Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or other targeted agents No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and neck No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart J. Wong, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36652-2144
Country
United States
Facility Name
St. Joseph's Mercy Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Auburn Radiation Oncology
City
Auburn
State/Province
California
ZIP/Postal Code
95603
Country
United States
Facility Name
Radiation Oncology Centers - Cameron Park
City
Cameron Park
State/Province
California
ZIP/Postal Code
95682
Country
United States
Facility Name
Mercy Cancer Center at Mercy San Juan Medical Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Radiation Oncology Center - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Radiological Associates of Sacramento Medical Group, Incorporated
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Solano Radiation Oncology Center
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Facility Name
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
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
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Saint Anthony's Hospital at Saint Anthony's Health Center
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
Rush-Copley Cancer Care Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60507
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Limited - West
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
City
Olympia Fields
State/Province
Illinois
ZIP/Postal Code
60461
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
Carle Cancer Center at Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
St. John's Cancer Center at St. John's Medical Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
St. Francis Hospital and Health Centers - Beech Grove Campus
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
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
Saint Anthony Memorial Health Centers
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
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
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
MaineGeneral Medical Center - Waterville Campus
City
Waterville
State/Province
Maine
ZIP/Postal Code
04901
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
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
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Breslin Cancer Center at Ingham Regional Medical Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
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
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
City
Gape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
David C. Pratt Cancer Center at St. John's Mercy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
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
Methodist Cancer Center at Methodist Hospital - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
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
Kingsbury Center for Cancer Care at Cheshire Medical Center
City
Keene
State/Province
New Hampshire
ZIP/Postal Code
03431
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
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
J. Phillip Citta Regional Cancer Center at Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
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
Long Island College Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Don Monti Comprehensive Cancer Center at North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Lenoir Memorial Cancer Center
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139
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, PC
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
McDowell Cancer Center at Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
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
Veterans Affairs Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Blanchard Valley Medical Associates
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Lima Memorial Hospital
City
Lima
State/Province
Ohio
ZIP/Postal Code
45804
Country
United States
Facility Name
Northwest Ohio Oncology Center
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Middletown Regional Hospital
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45044
Country
United States
Facility Name
St. Charles Mercy Hospital
City
Oregon
State/Province
Ohio
ZIP/Postal Code
43616
Country
United States
Facility Name
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
City
Salem
State/Province
Ohio
ZIP/Postal Code
44460
Country
United States
Facility Name
Firelands Regional Medical Center
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Flower Hospital Cancer Center
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
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
43617
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
Cancer Treatment Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
United States Air Force Medical Center - Wright-Patterson
City
Wright-Patterson Afb
State/Province
Ohio
ZIP/Postal Code
45433-5529
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Mercy Fitzgerald Hospital
City
Darby
State/Province
Pennsylvania
ZIP/Postal Code
19023
Country
United States
Facility Name
Alle-Kiski Medical Center
City
Natrona Heights
State/Province
Pennsylvania
ZIP/Postal Code
15065
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
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
AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
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
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
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
Cottonwood Hospital Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Regional Medical Center - Provo
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Dixie Regional Medical Center - East Campus
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Utah Cancer Specialists at UCS Cancer Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Latter Day Saints Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Norris Cotton Cancer Center - North
City
Saint Johnsbury
State/Province
Vermont
ZIP/Postal Code
05819
Country
United States
Facility Name
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
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
Community Memorial Hospital Cancer Care Center
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
Facility Name
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
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
All Saints Cancer Center at Wheaton Franciscan Healthcare
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States
Facility Name
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
West Allis Memorial Hospital
City
West Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

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