Status:
COMPLETED
Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Oropharynx Cancer
Oral Cancer
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In thi...
Detailed Description
Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32 fractions of 2 Gy BID o...
Eligibility Criteria
Inclusion
- palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx)
- primary tumor and / or nodal extension strictly inoperable due to the extension of the disease
- performance status of 0 to 2 (WHO scoring system)
- renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU
- signed inform consent
Exclusion
- distant metastasis
- previous history of cancer
- previous radiotherapy or chemotherapy
Key Trial Info
Start Date :
July 1 1996
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00162708
Start Date
July 1 1996
Last Update
September 13 2005
Active Locations (3)
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1
Centre Jean Perrin
Clermont-Ferrand, France
2
Centre Alexis Vautrin
Nancy, France
3
Institut Gustave Roussy
Villejuif, France, 94800