Concomitant Chemo-radiotherapy in Locally Advanced Non Small Cell Lung Cancer (BIB 01)
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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 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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;
Contacts and 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 | |
| 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: | December 29, 2011 |
| 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 May 23, 2013