Clinical trial · Interventional
Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy
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
NCT01839032CI-TRIAL-00010119completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinorelbine cisplatin radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vinorelbine cisplatin radiotherapy
- description
- Induction period + radio chemotherapy
- interventionNames
- Drug: Vinorelbine cisplatin radiotherapy
Primary outcomes (1)
- measure
- Disease controle
- timeFrame
- up to 3 years
Secondary outcomes (1)
- measure
- - duration of response (DR)
- timeFrame
- up to 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLerouge D, Riviere A, Dansin E, Chouaid C, Dujon C, Schott R, Lavole A, Le Pennec V, Fabre E, Crequit J, Martin F, Dehette S, Fournel P, Precheur-Agulhon B, Lartigau E, Zalcman G. A phase II study of cisplatin with intravenous and oral vinorelbine as induction chemotherapy followed by concomitant chemoradiotherapy with oral vinorelbine and cisplatin for locally advanced non-small cell lung cancer. BMC Cancer. 2014 Mar 30;14:231. doi: 10.1186/1471-2407-14-231. PMID 24678902