Status:
COMPLETED
Laryngeal Preservation in Pyriform Sinus Carcinoma
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Squamous Cell Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Patients were eligible if they had biopsy proven, previously untreated T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus. The study compare conventional radiotherapy with c...
Detailed Description
Objectives: To compare conventional radiotherapy with concurrent cisplatin to induction chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary end point was the pr...
Eligibility Criteria
Inclusion
- Patients were eligible if they had biopsy proven, previously untreated T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus.
- Patients also had to have a performance status (PS)\< 1, and normal organ functions as defined by an absolute neutrophil count \> 1500 cells/microl, platelet count \> 100 000 cells/microl and a calculated creatinine clearance of more than 50 ml/min.
Exclusion
- Patients with T1, T2 or T4 or M1 (metastatic disease) were ineligible.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00770393
Start Date
February 1 2002
End Date
June 1 2007
Last Update
October 10 2008
Active Locations (7)
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1
CALLOC'H
Aix-les-Bains, France
2
LITAS
Le Puy, France
3
PIGNAT
Lyon, France, 69000
4
MAYAUD
Montbrison, France