Status:
COMPLETED
Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC
Lead Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Conditions:
Oral Cancer
Oropharynx Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerate...
Detailed Description
This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant chemotherapy (arm B)...
Eligibility Criteria
Inclusion
- Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
- Stage III-IV (UICC 1997): T2, T3 or T4 with N0-N3 or T0 with N2-N3
- Not resectable
- Karnofsky PS \>= 70
- Renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-FU
- Informed consent signed
Exclusion
- Distant metastasis
- Contra-indication to concomitant chemotherapy
- History of cancer
- History of head and neck radiotherapy
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT00158652
Start Date
March 1 2000
End Date
March 1 2011
Last Update
November 8 2011
Active Locations (2)
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1
CHU de Tours
Tours, France, 37 044
2
Institut Gustave Roussy
Villejuif, France, 94800