Overview

This trial is active, not recruiting.

Conditions oral cancer, oropharynx cancer, hypopharynx cancer
Treatments imrt 75 gy, conventional radiotherapy 70 gy, concomitant cisplatin
Phase phase 3
Sponsor Groupe Oncologie Radiotherapie Tete et Cou
Start date September 2005
End date February 2018
Trial size 310 participants
Trial identifier NCT00158678, GORTEC 2004-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Conventional RT 70Gy + concomitant cisplatin
conventional radiotherapy 70 gy
50 Gy in PTV1 and 20 Gy in PTV2
concomitant cisplatin
100 mg/m2 D1, D22, D43
(Experimental)
IMRT 75Gy + concomitant cisplatin
imrt 75 gy
50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2
concomitant cisplatin
100 mg/m2 D1, D22, D43

Primary Outcomes

Measure
Loco regional control
time frame: 2 years

Secondary Outcomes

Measure
Survival
time frame: 2 years
Xerostomia at 2 years (evaluated by parotid gland scintigraphy)
time frame: 2 years
Quality of life (EORTC-QLQ-H&N35)
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma
Principal investigator Jean Bourhis, PhD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Groupe Oncologie Radiotherapie Tete et Cou.