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Sponsors and Collaborators: |
Institut Bergonié Sanofi-Aventis |
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Information provided by: | Institut Bergonié |
ClinicalTrials.gov Identifier: | NCT00210171 |
Feasibility of pragmatic concomitant chemo-radiotherapy association with 1 cycle of Induction chemotherapy, weekly chemo-radiotherapy, and consolidation chemotherapy.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Procedure: Toxicity : Time to progression, 1 and 2 years survival |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
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;
France | |
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest | |
Bordeaux, France, 33076 | |
Centre de radiothérapie d'Agen | |
Agen, France, 47000 | |
Centre Hospitalier Universitaire de Bordeaux | |
Bordeaux, France, 33076 | |
Hôpital Robert Boulin | |
Libourne, France, 33500 | |
Clinique Francheville | |
Perigueux, France, 24000 | |
Clinique Tivoli | |
Bordeaux, France, 33000 | |
Polyclinique Bordeaux Nord | |
Bordeaux, France, 33000 |
Principal Investigator: | François CHOMY, MD | Institut Bergonié |
Study ID Numbers: | IB2004-20, BIB-01 |
Study First Received: | September 12, 2005 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00210171 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Carcinoma Stage IIIA Non Small Cell Lung Stage IIIB Non-Small-Cell Lung Concomitant chemo-radiotherapy Consolidation chemotherapy |
Docetaxel Thoracic Neoplasms Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |