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Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer That Has Been Removed During Surgery

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
chemotherapy
cisplatin
low-LET cobalt-60 gamma ray therapy
low-LET electron therapy
low-LET photon 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 stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Biopsy-proven squamous cell carcinoma of one of the following sites: Hypopharynx Larynx Oral cavity Oropharynx At least 1 of the following high-risk factors required: Histologic extracapsular nodal extension Histologic involvement of 2 or more regional lymph nodes Microscopically positive mucosal margins Complete resection of all visible and palpable disease Therapy must begin within 8 weeks of tumor-related surgery Bilateral resections may or may not be performed simultaneously Eligibility window begins with first definitive surgery Neck dissection not required for T4 N0, truly midline supraglottic tumors No tumors of the lip, nasopharynx, or sinuses No synchronous or concurrent head and neck tumors No evidence of distant metastasis Concurrent registration on Fixed Tumor Repository Study allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 3,500 Platelets at least 100,000 Hepatic: Not specified Renal: Creatinine clearance greater than 50 mL/min Other: No medical contraindication to protocol therapy No second malignancy within 5 years No pregnant or nursing women PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head and neck region Surgery: See Disease Characteristics

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute
  • Emory University Hospital - Atlanta
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • CCOP - Evanston
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • Indiana University Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • CCOP - Kalamazoo
  • CCOP - Duluth
  • University of Minnesota Cancer Center
  • CCOP - Metro-Minnesota
  • CCOP - Missouri Valley Cancer Consortium
  • CCOP - Northern New Jersey
  • Ireland Cancer Center
  • CCOP - Toledo Community Hospital Oncology Program
  • CCOP - Sooner State
  • Veterans Affairs Medical Center - Nashville
  • Vanderbilt Cancer Center
  • Medical College of Wisconsin
  • Veterans Affairs Medical Center - Milwaukee (Zablocki)
  • Pretoria Academic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiation therapy

Radiation therapy plus cisplatin

Arm Description

Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week)

Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week) plus Cisplatin-100 mg/m2 i.v. on days 1,22 and 43 with radiation therapy.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 23, 2014
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group, SWOG Cancer Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT00002670
Brief Title
Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer That Has Been Removed During Surgery
Official Title
Phase III Intergroup Trial of Surgery Followed by (1) Radiotherapy vs. (2) Radiochemotherapy For Resectable High Risk Squamous Cell Carcinoma of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 1995 (undefined)
Primary Completion Date
July 2002 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy plus cisplatin is more effective than radiation therapy alone in treating patients with head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin with radiation therapy alone in treating patients with head and neck cancer that has been removed during surgery.
Detailed Description
OBJECTIVES: I. Evaluate locoregional control rates, patterns of first failure, and overall and disease-free survival in patients with advanced squamous cell carcinoma of the head and neck at high risk of locoregional recurrence who are treated postoperatively with concurrent cisplatin and radiotherapy. II. Compare the toxicity of concurrent chemoradiotherapy vs. radiotherapy alone in the postoperative setting. OUTLINE: Randomized study. Arm I: Radiotherapy. Involved-field irradiation using Co60, 1-6 MV photons, or electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation as in Arm I; plus Cisplatin, CDDP, NSC-119875. PROJECTED ACCRUAL: 438 patients will be entered over approximately 5 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
stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Radiation therapy
Arm Type
Active Comparator
Arm Description
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week)
Arm Title
Radiation therapy plus cisplatin
Arm Type
Experimental
Arm Description
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week) plus Cisplatin-100 mg/m2 i.v. on days 1,22 and 43 with radiation therapy.
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Radiation
Intervention Name(s)
low-LET cobalt-60 gamma ray therapy
Intervention Type
Radiation
Intervention Name(s)
low-LET electron therapy
Intervention Type
Radiation
Intervention Name(s)
low-LET photon therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Biopsy-proven squamous cell carcinoma of one of the following sites: Hypopharynx Larynx Oral cavity Oropharynx At least 1 of the following high-risk factors required: Histologic extracapsular nodal extension Histologic involvement of 2 or more regional lymph nodes Microscopically positive mucosal margins Complete resection of all visible and palpable disease Therapy must begin within 8 weeks of tumor-related surgery Bilateral resections may or may not be performed simultaneously Eligibility window begins with first definitive surgery Neck dissection not required for T4 N0, truly midline supraglottic tumors No tumors of the lip, nasopharynx, or sinuses No synchronous or concurrent head and neck tumors No evidence of distant metastasis Concurrent registration on Fixed Tumor Repository Study allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 3,500 Platelets at least 100,000 Hepatic: Not specified Renal: Creatinine clearance greater than 50 mL/min Other: No medical contraindication to protocol therapy No second malignancy within 5 years No pregnant or nursing women PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head and neck region Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay S. Cooper, MD, FACR, FACRO
Organizational Affiliation
NYU Langone Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James N. Endicott, MD, PA
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julie A. Kish, MD, FACP
Organizational Affiliation
Josephine Ford Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
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
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5265
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Sooner State
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Veterans Affairs Medical Center - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vanderbilt Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee (Zablocki)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Pretoria Academic Hospital
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
18794100
Citation
Schumaker L, Nikitakis N, Goloubeva O, Tan M, Taylor R, Cullen KJ. Elevated expression of glutathione S-transferase pi and p53 confers poor prognosis in head and neck cancer patients treated with chemoradiotherapy but not radiotherapy alone. Clin Cancer Res. 2008 Sep 15;14(18):5877-83. doi: 10.1158/1078-0432.CCR-08-0998.
Results Reference
background
PubMed Identifier
16161069
Citation
Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, Ozsahin EM, Jacobs JR, Jassem J, Ang KK, Lefebvre JL. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck. 2005 Oct;27(10):843-50. doi: 10.1002/hed.20279.
Results Reference
background
PubMed Identifier
22749632
Citation
Cooper JS, Zhang Q, Pajak TF, Forastiere AA, Jacobs J, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Lustig R, Ensley JF, Thorstad W, Schultz CJ, Yom SS, Ang KK. Long-term follow-up of the RTOG 9501/intergroup phase III trial: postoperative concurrent radiation therapy and chemotherapy in high-risk squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1198-205. doi: 10.1016/j.ijrobp.2012.05.008. Epub 2012 Jun 30.
Results Reference
result
Citation
Cooper JS, Pajak TF, Forastiere AA, et al.: Long-term survival results of a phase III intergroup trial (RTOG 95-01) of surgery followed by radiotherapy vs. radiochemotherapy for resectable high risk squamous cell carcinoma of the head and neck. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-25, S14-5, 2006.
Results Reference
result
PubMed Identifier
15128893
Citation
Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.
Results Reference
result
Citation
Cooper JS, Pajak TF, Forastiere AA, et al.: Postoperative concurrent radiochemotherapy in high-risk SCCA of the head and neck: initial report of RTOG 9501/intergroup phase III trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-903, 2002.
Results Reference
result
Citation
Cooper JS, Pajak TF, Forastiere AA, et al.: Patterns of failure for resected advanced head & neck cancer treated by concurrent chemotherapy and radiation therapy: an analysis of RTOG 9501/intergroup phase III trial. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): 2, 2002.
Results Reference
result

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Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer That Has Been Removed During Surgery

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