- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00158678
IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Vandoeuvre les Nancy, France, 54511
- Centre Alexis Vautrin
-
Villejuif, France, 94800
- Institut Gustave Roussy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
Conventional RT 70Gy + concomitant cisplatin
|
50 Gy in PTV1 and 20 Gy in PTV2
100 mg/m2 D1, D22, D43
|
EXPERIMENTAL: 2
IMRT 75Gy + concomitant cisplatin
|
100 mg/m2 D1, D22, D43
50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Loco regional control
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival
Time Frame: 2 years
|
2 years
|
Xerostomia at 2 years (evaluated by parotid gland scintigraphy)
Time Frame: 2 years
|
2 years
|
Quality of life (EORTC-QLQ-H&N35)
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michel Lapeyre, MD, Centre Alexis Vautrin
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GORTEC 2004-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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