drugset / Trial / NCT00003576

Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery

NCT00003576 ↗

Phase 3 Completed 200 enrolled National Cancer Centre, Singapore
RandomizedTreatment

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether surgery plus radiation therapy is more effective than chemotherapy plus radiation therapy for head and neck cancer. PURPOSE: This randomized phase III trial is studying surgery and radiation therapy to see how well they work compared to chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer that can be removed during surgery.

Timeline

Start
1997-01
Primary completion
—
Completion
2005-08

Outcome

Missed primary endpoint

paper Combination chemotherapy and concurrent irradiation with salvage surgery was not superior to conventional surgery and postoperative radiotherapy for resectable advanced squamous cell head and neck cancer. PMID 16012523 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 20 mg/m2 Intravenous
Subject fluorouracil Small molecule 1000 mg/m2 Intravenous

Indications