NCT01839032

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Vinorelbine cisplatin radiotherapy	During the induction period, patients received chemotherapy for two 3-week cycles. Bolus intravenous vinorelbine 25 mg/m², was administered on day 1, then cisplatin 80 mg/m² was administered over 1-hour infusion. Vinorelbine 60 mg/m² was also administered on day 8. Patients with objective response (OR) or no change (NC) continued the concomitant period (CP) including two additional 3-week cycles of radio chemotherapy (vinorelvine 20 mg D1 D3 D5 Cisplatin 80 mg/m² 66 Gy).

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2013-04-24
• Last updated: 2013-04-24

Locations

1 site across 1 country: France