Status:
WITHDRAWN
Concomitant Chemo-radiotherapy in Locally Advanced Non Small Cell Lung Cancer
Lead Sponsor:
Institut Bergonié
Collaborating Sponsors:
Sanofi
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Feasibility of pragmatic concomitant chemo-radiotherapy association with 1 cycle of Induction chemotherapy, weekly chemo-radiotherapy, and consolidation chemotherapy.
Eligibility Criteria
Inclusion
- 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;
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00210171
Start Date
May 1 2004
End Date
May 1 2004
Last Update
September 10 2025
Active Locations (7)
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1
Centre de radiothérapie d'Agen
Agen, France, 47000
2
Clinique Tivoli
Bordeaux, France, 33000
3
Polyclinique Bordeaux Nord
Bordeaux, France, 33000
4
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33076