Status:
COMPLETED
Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy
Lead Sponsor:
Pierre Fabre Medicament
Conditions:
Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non change received ...
Detailed Description
Vinorelbine (NVB) + CDDP is considered a standard trt in induction or concomitantly with RT (Vokes, Fournel, Krzakowski). NVBo simplifies the administration of trt and provides the same efficacy as in...
Eligibility Criteria
Inclusion
- histologically or cytologically confirmed stage IIIA (only N2),
- dry IIIB previously untreated inoperable NSCLC,
- 18 to 75 years old,
- Karnofsky Performance Status (KPS) ≥ 80%,
- weight loss ≤ 10% within the previous 3 months,
- normal organ functions were eligible.
- at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) \[10\].
Exclusion
- stages I, II, IIIA (excepted N2), IIIB with pleural effucion and stage IV,
- pregnant or breastfeeding women. Women of Childbearing Age: Women of childbearing potential should take reliable contraceptive measures
- Symptomatic Neuropathy \> grade 1,
- associated Pathology and/or not controled diseases(cardiac insuficiency, myocardial infarction within 3 months before the inclusion ; hypertension, arythmia or uncontroled hypercalcémia; infection requiering iv antibiotic administration within 2 weeks before inculion),
- other associated cancer with the exception of cervical carcinoma in situ or skin cancer baso-cellular correctely treated,
- Previous treatment with an other antineoplasic,
- Known hypersensibility to drugs with a similar chemical structure ti this studied.
- important malabsorbtion syndrom or disease of gastro-intestinal track,
- Participation to another clinical trial within 30 days before inclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01839032
Start Date
May 1 2005
End Date
October 1 2008
Last Update
April 24 2013
Active Locations (1)
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1
CHU CAEN
Caen, France, 14033