Concomitant Chemo-radiotherapy in Locally Advanced Non Small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

— BIB 01  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00210171
• Other study ID #: IB2004-20
• Secondary ID: BIB-01
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: July 25, 2013
• Start date: May 2004
• Est. completion date: March 2007

Study information

• Verified date: October 2007
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Procedure:
• Toxicity : Time to progression, 1 and 2 years survival

Locations

Country	Name	City	State
France	Centre de radiothérapie d'Agen	Agen
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Clinique Tivoli	Bordeaux
France	Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest	Bordeaux
France	Polyclinique Bordeaux Nord	Bordeaux
France	Hôpital Robert Boulin	Libourne
France	Clinique Francheville	Perigueux

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response
Secondary	Toxicity
Secondary	Time to progression
Secondary	1 and 2 years survival