Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy

NCT ID: NCT01839032

Last Updated: 2013-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-10-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vinorelbine cisplatin radiotherapy

Induction period + radio chemotherapy

Group Type: EXPERIMENTAL

Vinorelbine cisplatin radiotherapy

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Navelbine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Medicament

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gérard Zalcmann, professor

Role: STUDY_CHAIR

Baclesse, Caen, France

Locations

CHU CAEN

Caen, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 24678902 (View on PubMed)

Other Identifiers

041316

Identifier Type: -

Identifier Source: org_study_id