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.

Condition	Intervention	Phase
Oropharynx Cancer Oral Cancer Hypopharynx Cancer Larynx Cancer	Procedure: Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID)  Procedure: Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID)  Drug: CDDP, 5 Fu	Phase II Phase III

Further Study Details: 

Primary Outcomes: Event free survival (event = progressive disease or relapse or or death from any cause)
Secondary Outcomes: Survival; Toxicity
Expected Total Enrollment:  120

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.

Ages Eligible for Study:  40 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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

Exclusion Criteria:

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

France
      Institut Gustave Roussy, Villejuif,  94800,  France
      Centre Alexis Vautrin, Nancy,  France
      Centre Jean Perrin, Clermont-Ferrand,  France

Study chairs or principal investigators

Jean Bourhis,  Principal Investigator,  Institut Gustave Roussy   
Michel Lapeyre,  Principal Investigator,  Centre Alexis Vautrin   
Jacques Tortochaux,  Principal Investigator,  Centre Jean Perrin   

Study ID Numbers:  VADN3; GORTEC
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00162708
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13