Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
- Conditions
- Squamous Neck Carcinoma of the Head and Neck Cancer (SCCHN)
- Interventions
- Registration Number
- NCT00002774
- Lead Sponsor
- Stanford University
- Brief Summary
PURPOSE: Randomized phase 2 trial to compare the effectiveness of chemo-radiation therapy (RT + cisplatin + 5-FU) with or without tirapazamine for the treatment of patients with stage III or IV squamous cell carcinomas of the head and neck cancer (SCCHN).
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells.
Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making tumor cells more sensitive to therapy.
- Detailed Description
Subjects were stratified according to pO2 values (high vs low), and randomized to 1 of 2 treatment arms, differing by the addition of tirapazamine to the therapeutic regimen. Treatment consists of two 21-day cycles of induction chemotherapy, followed by radiotherapy (RT).
Induction chemotherapy was cisplatin 100 mg/m2 per day administered over 4 hours on Study Days 1 and 22 (ie, 1st day of both induction cycles) with continuous infusion (CI) 5-FU at a dose of 1000 mg/m2 per day for 120 hours per cycle starting on Study Days 1 and 22 (ie, days 1 to 5 of both induction cycles).
Patients who achieve at least partial response proceeded to chemoradiotherapy (CRT) consisting of localized RT + cisplatin IV + 5-FU +/- tirapazamine. Location of RT was based on whether the site had a CR or PR. Radiotherapy began on day 43 (week 1), and continued for 5.5 weeks. Subjects with no response or progressive disease proceeded to salvage surgery.
A total of 63 patients were accrued for this study over approximately 5 years. 1 subject withdrew consent prior to treatment for personal reasons.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cisplatin + 5-FU Radiotherapy (RT) 2 cycles of induction chemotherapy (cisplatin + 5-fluorouracil \[5-FU\]) followed by simultaneous chemoradiotherapy (cisplatin + 5-FU) Tirapazamine + cisplatin + 5-FU Cisplatin 2 cycles of induction chemotherapy (tirapazamine, cisplatin, and 5-fluorouracil \[5-FU\]) followed by simultaneous chemoradiotherapy (tirapazamine, cisplatin, and 5-FU) Cisplatin + 5-FU 5-fluorouracil 2 cycles of induction chemotherapy (cisplatin + 5-fluorouracil \[5-FU\]) followed by simultaneous chemoradiotherapy (cisplatin + 5-FU) Tirapazamine + cisplatin + 5-FU Radiotherapy (RT) 2 cycles of induction chemotherapy (tirapazamine, cisplatin, and 5-fluorouracil \[5-FU\]) followed by simultaneous chemoradiotherapy (tirapazamine, cisplatin, and 5-FU) Tirapazamine + cisplatin + 5-FU 5-fluorouracil 2 cycles of induction chemotherapy (tirapazamine, cisplatin, and 5-fluorouracil \[5-FU\]) followed by simultaneous chemoradiotherapy (tirapazamine, cisplatin, and 5-FU) Tirapazamine + cisplatin + 5-FU Tirapazamine 2 cycles of induction chemotherapy (tirapazamine, cisplatin, and 5-fluorouracil \[5-FU\]) followed by simultaneous chemoradiotherapy (tirapazamine, cisplatin, and 5-FU) Cisplatin + 5-FU Cisplatin 2 cycles of induction chemotherapy (cisplatin + 5-fluorouracil \[5-FU\]) followed by simultaneous chemoradiotherapy (cisplatin + 5-FU)
- Primary Outcome Measures
Name Time Method Complete response rate (CRR) 12 weeks Compare the CRR following CRT with or without tirapazamine in patients with squamous cell carcinoma of the head and neck.
- Secondary Outcome Measures
Name Time Method Cause-specific survival (CSS) 5 years CSS is also known as disease-specific survival (DSS), and in this study represents cancer survival from diagnosis until death due to cancer, in the absence of other causes of death. All other causes of death are censored.
Overall survival (OS) 5 years Survival was assessed at 5 years post-treatment.
Rate of freedom from recurrence (FFR) 5 years FFR is the period until first treatment failure, and typically includes failure to achieve CR, but does not include deaths.
Trial Locations
- Locations (2)
Veterans Affairs Medical Center - Palo Alto
🇺🇸Palo Alto, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States