Clinical trial NCT01839032: Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2013-04-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease controle
timeFrame: up to 3 years
Secondary outcomes:
measure: - duration of response (DR)
timeFrame: up to 3 years
Other outcomes:
measure: - progression-free survival (PFS)
timeFrame: up to 3 years
measure: - overall survival (OS),
timeFrame: up to 3 years
measure: - safety
timeFrame: up to 3 years
Locations:
city: Caen
country: France
facility: CHU CAEN
Study officials:
affiliation: Baclesse, Caen, France
name: Gérard Zalcmann, professor
role: STUDY_CHAIR
References:
citation: Lerouge 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.