Study Stopped
The study was withdrawn due to logistic issues.
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
2 other identifiers
interventional
N/A
1 country
7
Brief Summary
Feasibility of pragmatic concomitant chemo-radiotherapy association with 1 cycle of Induction chemotherapy, weekly chemo-radiotherapy, and consolidation chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2004
7 active sites
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
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedSeptember 10, 2025
September 1, 2025
Same day
September 12, 2005
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response
6 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Bergoniélead
- Sanoficollaborator
Study Sites (7)
Centre de radiothérapie d'Agen
Agen, 47000, France
Clinique Tivoli
Bordeaux, 33000, France
Polyclinique Bordeaux Nord
Bordeaux, 33000, France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33076, France
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, 33076, France
Hôpital Robert Boulin
Libourne, 33500, France
Clinique Francheville
Périgueux, 24000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François CHOMY, MD
Institut Bergonié
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 21, 2005
Study Start
May 1, 2004
Primary Completion
May 1, 2004
Study Completion
May 1, 2004
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share