EUCTR2008-005702-39-FR
Active, not recruiting
Phase 1
Phase I/II study of Induction Chemotherapy with weekly RAD001, Carboplatine and Paclitaxel in Unresectable or Inoperable Locally Advanced Head and NeckSquamous Cell Carcinoma (HNSCC) - CAPRA
GERCOR0 sites50 target enrollmentMarch 16, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- nresectable or Inoperable locally advanced head and neck squamous cellcarcinoma without any prior chemotherapy or radiotherapy
- Sponsor
- GERCOR
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •inclusion criteria
- •1\. Histologically proven squamous cell carcinoma of oral cavity, oropharynx,
- •larynx or hypopharynx
- •2\. Unresectable locally advanced disease (T4 N0\-N3 of the TNM classification,
- •or resectable with surgery contra\-indication).
- •3\. Presence of measurable lesions defined as those accurately measured in at
- •least one dimension (longest diameter to be recorded) as \> 20 mm with
- •conventional techniques or as \> 10 mm with spiral CT scan
- •4\. No prior therapy
- •5\. Age \= 18 years
Exclusion Criteria
- •Exclusion Criteria
- •1\. Stade I,II, III, IVc
- •2\. Chemotherapy or radiotherapy prior to the study
- •3\. Treatment with another investigational drug
- •4\. Participation in another therapeutic trial within the 30 days prior to entering this
- •5\. Uncontrolled disease such as diabetes, hypertension, symptomatic congestive
- •heart or pulmonary failure, renal or hepatic chronic diseases… (non
- •exhaustive list)
- •6\. Uncontrolled severe infectious disease, active hemorrhagic syndrome or anticoagulant
- •7\. Past history of cancer except in situ cervix cancer and baso\-cellular skin
Outcomes
Primary Outcomes
Not specified
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