Study:
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
Rationale:
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.
Purpose:
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
Recruiting:
n/a
| 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
ClinicalTrials.gov 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