Chemoradiotherapy of NSCLC Stage IIIB | NCT00198432

Studies
Chemoradiotherapy of NSCLC Stage IIIB

NCT00198432

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Status

Completed

Last Update Posted

Mar 10, 2016Estimated

Enrollment

130

Phase

Phase 2

Conditions

NSCLC Stage IIIB
Concomitant Radiochemotherapy

Interventions

Paclitaxel, vinorelbine, cisplatin

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2002

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2016

Last Update Posted Date

Mar 10, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Intergroupe Francophone de Cancerologie ThoraciqueOTHER

Collaborators

Name	Class
Bristol-Myers Squibb	INDUSTRY
Pierre Fabre Laboratories	INDUSTRY
Ligue contre le cancer, France	OTHER

Description Module

Brief Summary

To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.

Detailed Description

Chemotherapy:

C = Cisplatine : 80 mg/m² P = Paclitaxel : 200 mg/m² N = Vinorelbine : 15 mg/m²

Radiotherapy:

66 Gy with 33 fractions (2 Gy/fraction, 1 fraction/day, 6,5 weeks) High energy Photons X (>= 9MV)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130

Name	Type	Description	Arm Group Labels	Other Names
Paclitaxel, vinorelbine, cisplatin	Drug

Measure	Description	Time Frame
Objective response rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NSCLC stage IIIA N2 or IIIB not resectable, except N3 sus-clavicular, nor reached pleural
PS = 0 or 1
Possibility of including all the targets in only one exposure field
Slimming < 10% of the weight of the body
Functions hepatic, renal and hematologic normal
VEMS >40% and PaO2 >60 mmHg
written and signed informed consent

Exclusion criteria :

- NSCLC stage IV or wet-IIIB

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Fournel, Dr	Intergroupe Francophone de Cancerologie Thoracique	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Saint-Etienne Pneumologie		Saint-Etienne		42000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26689864	Result	Fournel P, Vergnenegre A, Robinet G, Lena H, Gervais R, Le Caer H, Souquet PJ, Chavaillon JM, Bozonnat MC, Daures JP, Chouaid C, Martel-Lafay I; GFPC and IFCT Team. Induction or consolidation chemotherapy for unresectable stage III non-small-cell lung cancer patients treated with concurrent chemoradiation: a randomised phase II trial GFPC - IFCT 02-01. Eur J Cancer. 2016 Jan;52:181-7. doi: 10.1016/j.ejca.2015.10.072. Epub 2015 Dec 12.

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Measure	Description	Time Frame
Overall survival
Time to progression
Relapse rate (local control)

ID	Term
D017239	Paclitaxel
D000077235	Vinorelbine
D002945	Cisplatin