Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known which regimen of cisplatin and fluorouracil combined with radiation therapy is more effective in treating resectable cancer of the hypopharynx or larynx.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of cisplatin and fluorouracil combined with radiation therapy in preserving the larynx in patients who have resectable cancer of the hypopharynx or larynx.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven squamous cell carcinoma of the head and neck, including:

• Stage III/IV cancer of the glottic or supraglottic larynx

• Eligible T4 tumor defined as:

• Bulging the valleculae

• Bulging the hyothyroid membrane

• Minimal thyroid cartilage invasion or suspicion of invasion on imaging

• Stage II/III/IV cancer of the pyriform sinus or of the hypopharyngeal aspect of the aryepiglottic fold (with or without extension to postcricoid area)

• No massive destruction of the thyroid cartilage

• No continuity between primary tumor and a lymph node

• Operable on first attempt (as assessed by head and neck surgeon) by classical total laryngectomy with or without partial pharyngectomy

• No requirement for extended surgery (circumferential pharyngolaryngectomy)

• No tumor suitable for partial (functional) surgery or requiring extended surgery that necessitates any kind of flap for closure

• No N2c tumor unless no requirement for bilateral resection of internal jugular veins

• Measurable or evaluable disease by panendoscopy and CT scan or MRI

• Esophagoscopy required

• Bronchofiberscopy recommended

• No requirement for tracheotomy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2 OR

• WHO 0-2

Hematopoietic:

• WBC at least 4,000/mm^3

Hepatic:

• Bilirubin no greater than 2.0 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance at least 60 mL/min

Other:

• No medical, psychological, or geographical condition that precludes study compliance

• No serious nonmalignant systemic disease

• No second malignancy except:

• Carcinoma in situ of the cervix

• Adequately treated nonmelanomatous skin cancer

• No poor nutritional status unlikely to be restored to fair status within 3 weeks

• No contraindication to CT scan or general anesthesia

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior anticancer biologic therapy

Chemotherapy

• No prior anticancer chemotherapy

Endocrine therapy

• No prior anticancer endocrine therapy

Radiotherapy

• No prior anticancer radiotherapy

Surgery

• See Disease Characteristics

Other

• No other prior anticancer therapy