NCT00084435

S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer

Adjuvant Chemo-RT With Cisplatin (NSC-119875) and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin and docetaxel works in treating patients with completely resected stage III or stage IV head and neck cancer.

Detailed description

OBJECTIVES: * Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin. * Determine the toxicity of this regimen in these patients. * Categorize the site(s) of disease relapse in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 17.5-23.5 months.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	75 mg/m2 IV, Day 1, q 21 days for 3 cycles
DRUG	docetaxel	15 mg/m2 IV, Day 1, 1 7 days for 6 doses
RADIATION	radiation therapy	200 cGy/day, Days 1-5, q week for 6 weeks

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2004-06-11
• Last updated: 2012-06-14

Locations

29 sites across 1 country: United States