NCT00003777

Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer

A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use 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. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.

Detailed description

OBJECTIVES: * Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer. * Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients. OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2, 4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy. Patients receive fluorouracil IV continuously on days 1-4 and 29-32. Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months thereafter. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	amifostine trihydrate
DRUG	cisplatin
DRUG	fluorouracil
PROCEDURE	surgical procedure
RADIATION	radiation therapy

Timeline

• Start date: 1998-12-01
• Primary completion: 2001-04-01
• Completion: 2001-04-20
• First posted: 2003-12-10
• Last updated: 2022-01-26

Locations

1 site across 1 country: United States