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S0427, Combination Chemotherapy & RT in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx


A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, With and Without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients With Advanced Oropharyngeal Squamous Cell Cancer


Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known whether giving combination chemotherapy together with radiation therapy is more effective than giving cisplatin together with radiation therapy in treating cancer of the oropharynx.


This randomized phase III trial is studying combination chemotherapy and radiation therapy to see how well they work compared to cisplatin and radiation therapy in treating patients with stage III or stage IV cancer of the oropharynx.

Study Status: Terminated


Condition Intervention Phase
Head and Neck Cancer Drug: cisplatin
Drug: docetaxel
Drug: 5-fluorouracil
Procedure: surgery
Radiation: radiation therapy
Phase 3

Verified by Southwest Oncology Group October, 2012

Sponsored by: Southwest Oncology Group
Information provided by: Southwest Oncology Group identifier: NCT00268372

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States

Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio 44131
United States

Cleveland Clinic - Wooster
Wooster, Ohio 44691
United States

David J. Adelstein, MD., Study Chair
Gregory T. Wolf, MD., Study Director
P. G. Shankar Giri, MD, MB, BS., Study Chair

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