IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC

Phase 3

Completed

• Conditions: Oral Cancer; Oropharynx Cancer; Hypopharynx Cancer
• Interventions: Procedure: Conventional radiotherapy 70 Gy; Procedure: IMRT 75 Gy; Drug: concomitant cisplatin

• Registration Number: NCT00158678
• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Study Start: 2005-09-27
• Primary Completion: 2020-03-22
• Study Completion: 2020-03-22
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Conventional radiotherapy 70 Gy	Conventional RT 70Gy + concomitant cisplatin
2	IMRT 75 Gy	IMRT 75Gy + concomitant cisplatin
2	concomitant cisplatin	IMRT 75Gy + concomitant cisplatin
1	concomitant cisplatin	Conventional RT 70Gy + concomitant cisplatin

Primary Outcome Measures

Name	Time	Method
Loco regional control	2 years

Secondary Outcome Measures

Name	Time	Method
Survival	2 years
Xerostomia at 2 years (evaluated by parotid gland scintigraphy)	2 years
Quality of life (EORTC-QLQ-H&N35)	2 years

Trial Locations

Locations (2)

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre les Nancy, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France