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

Groupe Oncologie Radiotherapie Tete et Cou

Status and phase: Completed; Phase 3

Conditions: Oropharynx Cancer; Hypopharynx Cancer; Oral Cancer

Treatments: Procedure: Conventional radiotherapy 70 Gy; Procedure: IMRT 75 Gy; Drug: concomitant cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00158678

GORTEC 2004-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

1

Active Comparator group

Description:

Conventional RT 70Gy + concomitant cisplatin

Treatment:

Drug: concomitant cisplatin

Procedure: Conventional radiotherapy 70 Gy

2

Experimental group

Description:

IMRT 75Gy + concomitant cisplatin

Treatment:

Procedure: IMRT 75 Gy

Drug: concomitant cisplatin