drugset / Trial / NCT00113399

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

NCT00113399 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and giving them with radiation therapy may kill more tumor cells. It is not yet known whether giving radiation therapy together with combination chemotherapy is more effective than giving combination chemotherapy alone in treating head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery.

Timeline

Start
2005-04
Primary completion
2009-02
Completion
—

Outcome

Outcome not reported

Stopped (Enrollment): “Terminated early due to low accrual.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified — Intravenous
Subject Docetaxel Small molecule — Intravenous
Subject Paclitaxel Small molecule — Intravenous
Subject fluorouracil Small molecule — Intravenous
Background filgrastim Protein / enzyme biologic — Subcutaneous

Indications