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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002670
• Other study ID #: RTOG-9501
• Secondary ID: CDR0000064279E-R
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: January 23, 2014
• Start date: September 1995
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: November 2013
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• chemotherapy

• cisplatin

Radiation:
• low-LET cobalt-60 gamma ray therapy

• low-LET electron therapy

• low-LET photon therapy

Locations

Country	Name	City	State
South Africa	Pretoria Academic Hospital	Pretoria
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	CCOP - Evanston	Evanston	Illinois
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Vanderbilt Cancer Center	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio
United States	CCOP - Sooner State	Tulsa	Oklahoma
United States	CCOP - Carle Cancer Center	Urbana	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	Eastern Cooperative Oncology Group, National Cancer Institute (NCI), Southwest Oncology Group

Countries where clinical trial is conducted

United States,  South Africa, 

References & Publications (8)

Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, Ozsahin EM, Jacobs JR, Jassem J, Ang KK, Lefèbvre 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. — View 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]

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

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:

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 an — View 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 — View Citation

Cullen KJ, Nikitakis N, Goloubeva O, et al.: Effect of elevated expression of GST-p and p53 on prognosis in head and neck cancer patients treated with chemoradiotherapy but not radiotherapy alone: An analysis of RTOG trials 9003 and 9501. [Abstract] J Clin Oncol 26 (Suppl 15): A-6013, 2008.

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. — View Citation