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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WITHDRAWN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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    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