Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

Phase 2

Completed

• Conditions: Oropharynx Cancer; Oral Cancer; Hypopharynx Cancer; Larynx Cancer

• Registration Number: NCT00162708
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.

Detailed Description

Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32 fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients responding (\> 50%) to the initial course of RT-CT. The end points were event free survival and survival.

Study Timeline

• Study Start: 1996-07
• Status Verified: 2005-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Last Update Submitted: 2005-09-09
• Study First Posted: 2005-09-13
• Last Update Posted: 2005-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx)
• primary tumor and / or nodal extension strictly inoperable due to the extension of the disease
• performance status of 0 to 2 (WHO scoring system)
• renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU
• signed inform consent

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Exclusion Criteria

• distant metastasis
• previous history of cancer
• previous radiotherapy or chemotherapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Event free survival (event = progressive disease or relapse or or death from any cause)

Secondary Outcome Measures

Name	Time	Method
Survival
Toxicity

Trial Locations

Locations (3)

Centre Alexis Vautrin; 🇫🇷 Nancy, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France