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Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Vinorelbine cisplatin radiotherapy

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU CAEN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vinorelbine cisplatin radiotherapy

Arm Description

Induction period + radio chemotherapy

Outcomes

Primary Outcome Measures

Disease controle

Secondary Outcome Measures

- duration of response (DR)

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.

Full Information

NCT ID

NCT01839032

First Posted

April 5, 2013

Last Updated

April 19, 2013

Sponsor

Pierre Fabre Medicament

1. Study Identification

Unique Protocol Identification Number

NCT01839032

Brief Title

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

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pierre Fabre Medicament

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vinorelbine cisplatin radiotherapy

Arm Type

Experimental

Arm Description

Induction period + radio chemotherapy

Intervention Type

Drug

Intervention Name(s)

Vinorelbine cisplatin radiotherapy

Other Intervention Name(s)

Navelbine

Intervention Description

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).

Primary Outcome Measure Information:

Title

Disease controle

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

- duration of response (DR)

Description

Time Frame

up to 3 years

Other Pre-specified Outcome Measures:

Title

- progression-free survival (PFS)

Time Frame

up to 3 years

Title

- overall survival (OS),

Time Frame

up to 3 years

Title

- safety

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gérard Zalcmann, professor

Organizational Affiliation

Baclesse, Caen, France

Official's Role

Study Chair

Facility Information:

Facility Name

CHU CAEN

City

Caen

ZIP/Postal Code

14033

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

24678902

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.

Results Reference

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Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy

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