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

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ClinicalTrials.gov Identifier: NCT00210171
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : July 26, 2013
Information provided by:
Institut Bergonié

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2004
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Objective response

Secondary Outcome Measures :
  1. Toxicity
  2. Time to progression
  3. 1 and 2 years survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210171

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

ClinicalTrials.gov Identifier: NCT00210171     History of Changes
Other Study ID Numbers: IB2004-20
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 26, 2013
Last Verified: October 2007

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

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