A Phase III Randomized Trial Comparing Single Agent Cisplatin With the Combination of 5-Fluorouracil and Cisplatin, Concurrent With Radiation Therapy in Stage III and IV Squamous Cell Head and Neck Cancer
- To compare the relapse-free survival of patients treated with radiotherapy and
cisplatin with vs without fluorouracil.
- To compare the overall survival, local control without surgery, and patterns of failure
in patients treated with these regimens.
- To compare the acute and long-term toxicity of these regimens in these patients.
- To compare the quality of life of patients treated with these regimens.
- To prospectively collect biopsy material, mucosal scrapings, and serum in an effort to
generate hypotheses for future correlative studies.
OUTLINE: This is a multicenter study. Patients are stratified according to radiotherapy
schedule (once daily vs twice daily) and radiotherapy planning (2D vs 3D vs
intensity-modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up
to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
- Arm II: Patients undergo radiotherapy as in arm I and receive fluorouracil IV and
cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Patients with biopsy-verified residual disease at the primary site or local recurrence after
achieving a complete response to chemoradiotherapy may undergo salvage surgery 12 weeks
after the completion of chemoradiotherapy.
Patients complete questionnaires periodically to assess late toxicity and quality of life.
After completion of study treatment, patients are followed periodically.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical Response-complete disappearance of detectable tumor
Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.
at 12 weeks after completing chemoradiotherapy
David J. Adelstein, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|