Clinical trial NCT00210171: Concomitant Chemo-radiotherapy in Locally Advanced Non Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma
Stage IIIA Non Small Cell Lung
Stage IIIB Non-Small-Cell Lung
Concomitant chemo-radiotherapy
Consolidation chemotherapy
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-09-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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;

Primary outcomes:
measure: Objective response
Secondary outcomes:
measure: Toxicity
measure: Time to progression
measure: 1 and 2 years survival
Other outcomes:
Locations:
city: Agen
country: France
facility: Centre de radiothérapie d'Agen
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
city: Libourne
country: France
facility: Hôpital Robert Boulin
city: Perigueux
country: France
facility: Clinique Francheville
Study officials:
affiliation: Institut Bergonié
name: François CHOMY, MD
role: PRINCIPAL_INVESTIGATOR
References: