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

NCT ID: NCT00002670

Last Updated: 2014-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 459 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-09-30
• Study Completion Date: 2013-11-30

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation therapy

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

Group Type: ACTIVE_COMPARATOR

low-LET cobalt-60 gamma ray therapy

Intervention Type: RADIATION

low-LET electron therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

Radiation therapy plus cisplatin

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.

Group Type: EXPERIMENTAL

chemotherapy

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

low-LET cobalt-60 gamma ray therapy

Intervention Type: RADIATION

low-LET electron therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

Interventions

chemotherapy

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

low-LET cobalt-60 gamma ray therapy

Intervention Type: RADIATION

low-LET electron therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay S. Cooper, MD, FACR, FACRO

Role: STUDY_CHAIR

NYU Langone Health

James N. Endicott, MD, PA

Role: STUDY_CHAIR

H. Lee Moffitt Cancer Center and Research Institute

Julie A. Kish, MD, FACP

Role: STUDY_CHAIR

Josephine Ford Cancer Center

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Emory University Hospital - Atlanta

Atlanta, Georgia, United States

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, United States

CCOP - Evanston

Evanston, Illinois, United States

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

CCOP - Duluth

Duluth, Minnesota, United States

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

CCOP - Northern New Jersey

Hackensack, New Jersey, United States

Ireland Cancer Center

Cleveland, Ohio, United States

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, United States

CCOP - Sooner State

Tulsa, Oklahoma, United States

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, United States

Vanderbilt Cancer Center

Nashville, Tennessee, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, United States

Pretoria Academic Hospital

Pretoria, , South Africa

Countries

United States; South Africa

References

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.

Reference Type: BACKGROUND

PMID: 18794100 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16161069 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22749632 (View on PubMed)

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.

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 15128893 (View on PubMed)

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.

Reference Type: RESULT

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.

Reference Type: RESULT

Other Identifiers

CDR0000064279

Identifier Type: -

Identifier Source: secondary_id

E-R9501

Identifier Type: -

Identifier Source: secondary_id

SWOG-9515

Identifier Type: -

Identifier Source: secondary_id

RTOG-9501

Identifier Type: -

Identifier Source: org_study_id