Status:
COMPLETED
IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC
Lead Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Conditions:
Oral Cancer
Oropharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-I...
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 sta...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 27 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 22 2020
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00158678
Start Date
September 27 2005
End Date
March 22 2020
Last Update
April 15 2020
Active Locations (2)
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1
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54511
2
Institut Gustave Roussy
Villejuif, France, 94800