Concomitant Chemo-radiotherapy in Locally Advanced Non Small Cell Lung Cancer (BIB 01)

This study has been terminated.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210171
First received: September 12, 2005
Last updated: July 25, 2013
Last verified: October 2007
  Purpose

Feasibility of pragmatic concomitant chemo-radiotherapy association with 1 cycle of Induction chemotherapy, weekly chemo-radiotherapy, and consolidation chemotherapy.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Procedure: Toxicity : Time to progression, 1 and 2 years survival
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • Objective response

Secondary Outcome Measures:
  • Toxicity
  • Time to progression
  • 1 and 2 years survival

Enrollment: 3
Study Start Date: May 2004
Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210171

Locations
France
Centre de radiothérapie d'Agen
Agen, France, 47000
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33076
Polyclinique Bordeaux Nord
Bordeaux, France, 33000
Clinique Tivoli
Bordeaux, France, 33000
Hôpital Robert Boulin
Libourne, France, 33500
Clinique Francheville
Perigueux, France, 24000
Sponsors and Collaborators
Institut Bergonié
Sanofi
Investigators
Principal Investigator: François CHOMY, MD Institut Bergonié
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00210171     History of Changes
Other Study ID Numbers: IB2004-20, BIB-01
Study First Received: September 12, 2005
Last Updated: July 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Carcinoma
Stage IIIA Non Small Cell Lung
Stage IIIB Non-Small-Cell Lung
Concomitant chemo-radiotherapy
Consolidation chemotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014