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

WithdrawnPhase 2

Sponsor: Institut Bergonié

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Toxicity : Time to progression, 1 and 2 years survival

Countries: France

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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;

Locations (7)

Agen, France
Bordeaux, France
Bordeaux, France
Bordeaux, France
Bordeaux, France
Libourne, France
Périgueux, France