This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

Condition	Intervention	Phase
Oral Cancer Oropharynx Cancer Hypopharynx Cancer	Procedure: IMRT 75 Gy  Procedure: Conventional radiotherapy 70 Gy  Drug: concomitant cisplatin	Phase III

Further Study Details: 

Primary Outcomes: Loco regional control
Secondary Outcomes: Survival; Xerostomia at 2 years (evaluated by parotid gland scintigraphy); Quality of life (EORTC-QLQ-H&N35)
Expected Total Enrollment:  310

This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

The IMRT total dose is 75 Gy (50 Gy to PTV1 and T0 + 25 Gy (10 fractions) to PTV2). The conventional radiotherapy total dose is 70 Gy (50 Gy to PTV1 + 20 Gy (10 fractions) to PTV2). In both arms, the cervical nodes will receive 50 Gy (65 Gy in case of Np) by conventional radiotherapy (IMRT is allowed in the IRMT arm). In the two arms, patients will receive concomitant cisplatin (100 mg/m² D1, D21, D42).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• squamous cell carcinoma of oral cavity, oropharynx or hypopharynx
• Stage III – IV (T1-T4, N0-N2)(UICC 2002)
• Not resected
• Indication of radiotherapy to bilateral cervical nodes at dose>= 50 Gy
• Delineation of target volumes done before randomization
• Scintigraphy of parotid gland done before radiotherapy start
• Quality of life questionnaires (EORTC-C30 and EORTC-H&N35) filled in by the patient
• Informed consent signed

Exclusion Criteria:

• N3 (UICC 2002)
• Distant metastasis
• Contra-indication to concomitant cisplatin
• History of cancer within the last 5 years
• History of head and neck radiotherapy
• Administration of drugs for treatment or prophylaxis of xerostomia (pilocarpine, ethyol)

Please refer to this study by ClinicalTrials.gov identifier  NCT00158678

Jean Bourhis, PhD       bourhis@igr.fr
Michel Lapeyre, MD       lapeyre@nancy.fnclcc.fr

France
      Institut Gustave Roussy, Villejuif,  94800,  France; Recruiting
      Centre Alexis Vautrin, Vandoeuvre-les-Nancy,  54511,  France; Not yet recruiting
      CHU Poitiers - Hôpital Jean Bernard, Poitiers,  86021,  France; Not yet recruiting

Study chairs or principal investigators

Jean Bourhis, PhD,  Principal Investigator,  Institut Gustave Roussy   
Michel Lapeyre, MD,  Principal Investigator,  Centre Alexis Vautrin   

Study ID Numbers:  GORTEC 2004-01
Last Updated:  September 11, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00158678
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13