Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: Vinorelbine cisplatin radiotherapy

• Registration Number: NCT01839032
• Lead Sponsor: Pierre Fabre Medicament

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 NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more cycles during RT(66 Gy/6.5 w).

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 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.

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2013-04
• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-19
• Last Update Submitted: 2013-04-19
• Study First Posted: 2013-04-24
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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].

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vinorelbine cisplatin radiotherapy	Vinorelbine cisplatin radiotherapy	Induction period + radio chemotherapy

Primary Outcome Measures

Name	Time	Method
Disease controle	up to 3 years

Secondary Outcome Measures

Name	Time	Method
- duration of response (DR)	up to 3 years	Secondary endpoints were duration of response (DR), progression-free survival (PFS), and overall survival (OS), calculated by the Kaplan-Meier method. The safety analysis reported the worst grade of the adverse events (NCI CTC v. 2.0) for the safety population.

Trial Locations

Locations (1)

CHU CAEN; 🇫🇷 Caen, France