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

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Trial Conditions
  • Head and Neck Cancer
What is the purpose of this trial?

RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer. PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

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

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

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- Alanine aminotransferase (ALT) or aspartate aminotransferase (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

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

Gender: Both
Steward Physician(s)
  • Phuc Felix Nguyen-Tan, MD
Facilities
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
Drug
  • cisplatin
Procedure
  • Conventional surgery for select patients
Radiation
  • Standard fractionation RT
  • Accelerated fractionation radiation therapy
Physician Researcher

Investigator Name:

  • Phuc Felix Nguyen-Tan, MD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00047008
Volunteers:  Not Accepting Healthy Volunteers

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