Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	RTOG-0129 RTOG-H-0129, RTOG-DEV-1069, NCT00047008

Objectives

Primary

1. Compare overall survival of patients with stage III or IV squamous cell carcinoma of the head and neck treated with conventional vs accelerated radiotherapy and concurrent cisplatin with or without surgical resection.

Secondary

1. Compare local-regional control of disease and disease-free rates in patients treated with these regimens.
2. Compare the acute and late toxicity of these regimens in these patients.
3. Compare quality of life, perception of side effects, and performance status of patients treated with these regimens.
4. Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions are independent prognostic markers in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
  • Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)



• No metastases below the clavicle or more distant by clinical exam or radiology

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to the head and neck except radioactive iodine therapy

Surgery

• No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease
  • No radical or modified neck dissection

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 2,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• ALT or AST no greater than 2 times upper limit of normal

Renal

• Creatinine no greater than 1.5 mg/dL
• Creatinine clearance at least 50 mL/min
• Calcium normal

Cardiovascular

• No symptomatic coronary artery disease (angina)
• No myocardial infarction within the past 6 months

Other

• No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
• No simultaneous primary tumors
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 720 patients (360 per treatment arm) will be accrued for this study within 3 years.

Outline

This is a randomized, multicenter study. Patients are stratified according to tumor site (larynx vs other), nodal stage (N0 vs N1 or N2a or N2b vs N2c or N3), and Zubrod performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo standard fractionation radiotherapy 5 days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 22, and 43.



• Arm II: Patients undergo accelerated fractionation radiotherapy 5 days a week for 3.5 weeks and then twice a day, 5 days a week, for 2.5 weeks. Patients also receive cisplatin IV on days 1 and 22.

Patients with biopsy-proven relapsed disease more than 3 months after completion of therapy undergo surgical resection of the primary tumor.

Quality of life is assessed at baseline, during one of the last 2 weeks of treatment, at 3 and 12 months, and then annually for 4 years.

Patients are followed at 6-8 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Gillison ML, Harris J, Westra W, et al.: Survival outcomes by tumor human papillomavirus (HPV) status in stage III-IV oropharyngeal cancer (OPC) in RTOG 0129. [Abstract] J Clin Oncol 27 (Suppl 15): A-6003, 2009.

Ang K, Pajak T, Rosenthal DI, et al.: A phase III trial to compare standard versus accelerated fractionation in combination with concurrent cisplatin for head and neck carcinomas (RTOG 0129): report of compliance and toxicity. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-21, S12-13, 2007.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

K. Kian Ang, MD, PhD, Protocol chair		Ph: 713-563-2300; 800-392-1611

Registry Information
Official Title		A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
Trial Start Date		2002-07-30
Registered in ClinicalTrials.gov		NCT00047008
Date Submitted to PDQ		2002-08-02
Information Last Verified		2005-06-15
NCI Grant/Contract Number		CA21661

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