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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 69
- Locations
- 2
- Primary Endpoint
- Relapse Free Survival
Study Overview
Brief Summary
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as 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. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.
Detailed Description
OBJECTIVES:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A: Radiation with concurrent Cisplatin
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.
Intervention: cisplatin (Drug)
Arm A: Radiation with concurrent Cisplatin
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.
Intervention: radiation therapy (Radiation)
Arm B: Radiation with concurrent 5-FU and Cisplatin
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Intervention: cisplatin (Drug)
Arm B: Radiation with concurrent 5-FU and Cisplatin
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Intervention: fluorouracil (Drug)
Arm B: Radiation with concurrent 5-FU and Cisplatin
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Intervention: radiation therapy (Radiation)
Outcomes
Primary Outcomes
Relapse Free Survival
Time Frame: at 2 yrs from start of study
Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..
Secondary Outcomes
- Eating(24 months from start of treatment)
- Disease Recurrence(2 years after start of study)
- Number of Patients That Required a Feeding Tube(24 months after start of treatment)
- Nausea Level(24 months from start of treatment)
- Swallowing(24 months after start of treatment)
- Pain(24 months from start of treatment)
- Quality of Life(24 months from start of treatment)
- Alcohol Consumption(24 months after start of treatment)
- Overall Survival(2 yrs from start of study)
- Patterns of Failure(2 years from start of study)
- Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor(at 12 weeks after completing chemoradiotherapy)
- Solid Foods(24 months after start of treatment)
- Number of Patients With a Pathological(Final)Complete Response(at 12 weeks after completing chemoradiotherapy and surgery)
- Dry Mouth(24 months from start of treatment)