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A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas

Phase 3
18 Years
Not Enrolling
Head and Neck Cancer

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Trial Information

A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas



- 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.


- Compare local-regional control of disease and disease-free rates in patients treated
with these regimens.

- Compare the acute and late toxicity of these regimens in these patients.

- Compare quality of life, perception of side effects, and performance status of patients
treated with these regimens.

- Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions
are independent prognostic markers in patients treated with these regimens.

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.

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

Inclusion Criteria


- 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



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Absolute granulocyte count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2
times upper limit of normal


- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 50 mL/min

- Calcium normal


- No symptomatic coronary artery disease (angina)

- No myocardial infarction within the past 6 months


- 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


Biologic therapy

- Not specified


- No prior chemotherapy

Endocrine therapy

- Not specified


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


- No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal
sampling of neck disease

- No radical or modified neck dissection

Type of Study:


Study Design:

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

Outcome Measure:

Overall Survival

Outcome Time Frame:

From randomization to date of death or last follow-up. Analysis occurs after 309 deaths have been reported.

Safety Issue:


Principal Investigator

K. Kian Ang, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:

RTOG 0129



Start Date:

July 2002

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • Head and Neck Neoplasms



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