NCT00295672

Brief Summary

Our aim is to conducted a multicenter phase II trial of the cisplatin-oral vinorelbine -radiotherapy combination after induction chemotherapy with cisplatin-docetaxel in patient with NSCLC. Oral vinorelbine will be used in the present study rather than the intravenous form because: 1- Previous investigations have demonstrated that oral vinorelbine is as effective as the intravenous form in the treatment of NSCLC. 2 - We think that the use of oral agents in CT will reduce some disagreements provoked by intravenous injections: stress, infections, hemorrhage, displacement at the hospital and cost of CT. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

July 28, 2009

Status Verified

July 1, 2009

First QC Date

February 23, 2006

Last Update Submit

July 24, 2009

Conditions

Lung Neoplasm

Keywords

Non-Small-Cell Lung,radiotherapy, Chemotherapy, vinorelbine

Outcome Measures

Primary Outcomes (2)

  • TUMORAL RESPONSE (RECIST)

  • TOXICITY (NCI 20)

Secondary Outcomes (3)

  • SURVIVAL

  • TIME TO PROGRESSION

  • LATE RADIATION TOXICITY

Interventions

VinorelbineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically or cytologically documented inoperable stage IIIA N2 or IIIB NSCLC previously untreated, absence of malignant pleural effusion, performance status (PS) =1 and patient life expectancy of at least 12 weeks.

You may not qualify if:

  • metastatic disease, small Cell lung carcinoma, prior chemotherapy, prior radiotherapy, resecable tumor, any instable systemic disease, any other malignancies within 5 years,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU of Brest

Brest, 29250, France

Location

CH GAP

Gap, 05000, France

Location

CHU de LIMOGES

Limoges, 87042, France

Location

Hopital de la Croix Rousse

Lyon, 69317, France

Location

Hôpital Sainte Margueritte

Marseille, 13274, France

Location

CHU Hôpital Nord

Saint-Etienne, 42055, France

Location

Related Publications (2)

  • Fournel P, Robinet G, Thomas P, Souquet PJ, Lena H, Vergnenegre A, Delhoume JY, Le Treut J, Silvani JA, Dansin E, Bozonnat MC, Daures JP, Mornex F, Perol M; Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie. Randomized phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer: Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie NPC 95-01 Study. J Clin Oncol. 2005 Sep 1;23(25):5910-7. doi: 10.1200/JCO.2005.03.070. Epub 2005 Aug 8.

    PMID: 16087956BACKGROUND

  • Vergnenegre A, Daniel C, Lena H, Fournel P, Kleisbauer JP, Le Caer H, Letreut J, Paillotin D, Perol M, Bouchaert E, Preux PM, Robinet G; Groupe Francais de Pneumo-Cancerologie. Docetaxel and concurrent radiotherapy after two cycles of induction chemotherapy with cisplatin and vinorelbine in patients with locally advanced non-small-cell lung cancer. A phase II trial conducted by the Groupe Francais de Pneumo-Cancerologie (GFPC). Lung Cancer. 2005 Mar;47(3):395-404. doi: 10.1016/j.lungcan.2004.08.010.

    PMID: 15713523BACKGROUND

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • gilles Robinet

    CHU of Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2006

First Posted

February 24, 2006

Study Start

February 1, 2006

Study Completion

June 1, 2007

Last Updated

July 28, 2009

Record last verified: 2009-07

Locations

FR(6)