Brief Title
IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC
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
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
Loco regional control
Secondary Outcome
Survival
Condition
Oral Cancer
Intervention
IMRT 75 Gy
Study Arms / Comparison Groups
1
Description: Conventional RT 70Gy + concomitant cisplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
310
Start Date
September 27, 2005
Completion Date
March 22, 2020
Primary Completion Date
March 22, 2020
Eligibility 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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jean Bourhis, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00158678
Organization ID
GORTEC 2004-01
Responsible Party
Sponsor
Study Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Study Sponsor
Jean Bourhis, PhD, Principal Investigator, Gustave Roussy, Cancer Campus, Grand Paris
Verification Date
April 2020