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

• Status: Completed
• Trial end date: 2020-03-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Treatments: Cisplatin

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)