Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer

Phase 3

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00003888
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief 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. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for advanced head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy plus radiation therapy in treating patients who have advanced head and neck cancer.

Detailed Description

OBJECTIVES: I. Compare the progression free survival of patients with locally advanced, inoperable squamous cell carcinoma of the head and neck treated with cisplatin plus fluorouracil with or without docetaxel as a neoadjuvant to radiotherapy. II. Compare the response rate, response duration, toxicity, local symptoms, and time to disease progression of these treatment regimens in this patient population. III. Evaluate the quality of life in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary tumor site (oral cavity vs oropharynx vs hypopharynx vs larynx) and institution. Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel IV over 1 hour, immediately followed by cisplatin IV over 1 hour on day 1 and fluorouracil (5-FU) IV as a continuous infusion on days 1-5. Arm II: Patients receive cisplatin IV over 1 hour on day 1 followed by 5-FU IV as a continuous infusion on days 1-5. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients receive radiotherapy following chemotherapy within 3-6 weeks of last course. Radiotherapy is administered 5 days a week for up to 7 weeks. Quality of life is assessed before treatment, at courses 2 and 4, and at 6 and 9 months. Patients are followed every 3 months for the first 2 years and then every 6 months until death.

PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study within 24 months.

Study Timeline

• Study Start: 1999-04
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-03
• Study First Submitted QC: 2004-01-28
• Study First Posted: 2004-01-29
• Study Completion: 2015-03
• Status Verified: 2015-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 359

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (44)

Landeskrankenhaus/Universitatskliniken Graz; 🇦🇹 Graz, Austria

Allgemeines Krankenhaus der Stadt Wien; 🇦🇹 Vienna, Austria

Kaiser Franz Josef Hospital; 🇦🇹 Vienna, Austria

Algemeen Ziekenhuis Middelheim; 🇧🇪 Antwerp, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Centre Hospitalier Regional de la Citadelle; 🇧🇪 Liege, Belgium

Clinique Universitaire De Mont-Godinne; 🇧🇪 Mont-Godinne Yvoir, Belgium

Institute of Oncology and Radiology of Serbia; Belgrade, Former Yugoslavia

CHR de Besancon - Hopital Jean Minjoz; 🇫🇷 Besancon, France

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