Concomitant Chemo-radiotherapy in Locally Advanced Non Small Cell Lung Cancer (BIB 01)
Multicentric Phase II Study of Concomitant Chemo-radiotherapy in Locally Advanced Non Small Cell Lung Cancer, With :- Induction Chemotherapy by Cisplatin - Docetaxel- Concomitant Chemo-radiotherapy by Weekly Cisplatin - Docetaxel- Consolidation Chemotherapy by Docetaxel
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Agen, France, 47000
- Centre de radiothérapie d'Agen
-
Bordeaux, France, 33000
- Clinique Tivoli
-
Bordeaux, France, 33000
- Polyclinique Bordeaux Nord
-
Bordeaux, France, 33076
- Centre hospitalier universitaire de Bordeaux
-
Bordeaux, France, 33076
- Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
-
Libourne, France, 33500
- Hôpital Robert Boulin
-
Périgueux, France, 24000
- Clinique Francheville
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
Histologically or cytologically confirmed newly diagnosed, untreated, unresectable stage IIIA or stage IIIB non-small cell lung cancer Not scheduled for curative cancer surgery No pleural effusion At least 1 bidimensionally or unidimensionally measurable lesion Age 18 years et 70 years; Performance Status < 2 Loss of weight < 10 % in past 6 months life expectancy 12 weeks; Bilirubin normal ASAT (SGOT) et ALAT (SGPT) 1,5 times upper limit of normal; Alcalin phosphatases 5 times upper limit of normal; Créatinin 1,5 x times upper limit of normal; Absolute neutrophil count greater than 2.109/l; Platelet count greater than 100.109/l; Hémoglobin ³ 10 g/ dl; Respiratory function : FEV1>50% write Consent
Exclusion criteria:
Pregnant or nursing; Fertile patients who don't used effective contraception; No other malignancy within past 5 years except inactive carcinoma in situ of the cervix or nonmelanoma skin cancer ; Neuropathy grade NCI-CTC 2; Past thoracic radiotherapy; Past chemotherapy, immunotherapy or biologic therapy for non small cell lung cancer ; Respiratory deficiency FEV1 < 45% ; Hypersensibility to docetaxel or cisplatin; At least 4 weeks since other concurrent investigational agents;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Objective response
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Toxicity
|
|
Time to progression
|
|
1 and 2 years survival
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: François CHOMY, MD, Institut Bergonie
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IB2004-20
- BIB-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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