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Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Cancer of the Larynx

Sponsored by Radiation Therapy Oncology Group

About this trial

Last updated 11 years ago

Study ID

RTOG-9111

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 12 years ago

What is this trial about?

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. It is not yet known if chemotherapy plus radiation therapy is more effective than radiation therapy alone in treating patients with advanced cancer of the larynx. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients with advanced cancer of the larynx.

What are the Participation Requirements?

DISEASE CHARACTERISTICS: Biopsy-proven, previously untreated, squamous cell carcinoma of
the glottic and supraglottic larynx that would normally require total laryngectomy Stage
III/IV disease (excluding T1 and M1) Endoscopic tumor staging required within 4 weeks of
entry Tumors must be considered resectable and potentially curable with conventional
surgery and radiotherapy T4 disease limited to: Up to 1 cm invasion of the base of tongue
Questionable cartilage invasion on CT (clinically T3) Measurable disease required No
synchronous primary tumors No subglottic tumors

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100%
Hematopoietic: (obtained within 3 weeks of entry) WBC at least 3,500 Platelets at least
100,000 Hepatic: Not specified Renal: (obtained within 2 weeks of entry) Creatinine
clearance at least 50 mL/min (measured or calculated) Serum calcium normal
Cardiovascular: Status adequate to tolerate all protocol therapy Pulmonary: Status
adequate to tolerate all protocol therapy Other: Nutritional status adequate to tolerate
all protocol therapy Mental status adequate to follow instructions and keep appointments
No second malignancy except nonmelanomatous skin cancer (Patients who have been
disease-free for at least 3 years following treatment for a prior cancer may be eligible
at the discretion of the protocol chairman) Negative pregnancy test required of fertile
women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior
therapy Endocrine therapy: No prior therapy Radiotherapy: No prior radiotherapy to the
head and neck Surgery: No prior therapy

Locations

Location

Status