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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Oral Cancer, Oropharynx Cancer, Hypopharynx Cancer

Intervention / Treatment
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* Procedure: IMRT 75 Gy
* Procedure: Conventional radiotherapy 70 Gy
* Drug: concomitant cisplatin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Conventional RT 70Gy + concomitant cisplatin | Procedure: Conventional radiotherapy 70 Gy<br>* 50 Gy in PTV1 and 20 Gy in PTV2<br>Drug: concomitant cisplatin<br>* 100 mg/m2 D1, D22, D43<br>|
| Experimental: 2<br>IMRT 75Gy + concomitant cisplatin | Procedure: IMRT 75 Gy<br>* 50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2<br>Drug: concomitant cisplatin<br>* 100 mg/m2 D1, D22, D43<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loco regional control |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 2 years | 
| Xerostomia at 2 years (evaluated by parotid gland scintigraphy) |  | 2 years | 
| Quality of life (EORTC-QLQ-H&N35) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral cancer, oropharynx cancer, hypopharynx cancer, IMRT