A Phase II Study of Cisplatin With Intravenous and Oral Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemotherapy With Oral Vinorelbine and Cisplatine for Locally Advances Non-small Cell Lung Cancer
18 Years
75 Years
Both
Lung Cancer
Trial Information
A Phase II Study of Cisplatin With Intravenous and Oral Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemotherapy With Oral Vinorelbine and Cisplatine for Locally Advances Non-small Cell Lung Cancer
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 intravenous NVB (NVBiv). In order to assess this and to improve the
tolerance, a trial was started with NVBiv and NVBo + CDDP as induction followed by a
fractionated administration of NVBo + CDDP during RT.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease controle
Outcome Time Frame:
up to 3 years
Safety Issue:
No
Principal Investigator
Gérard Zalcmann, professor
Investigator Role:
Study Chair
Investigator Affiliation:
Baclesse, Caen, France
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
041316
NCT ID:
NCT01839032
Start Date:
May 2005
Completion Date:
October 2008
Related Keywords:
- Lung Cancer
- Lung Neoplasms
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