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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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

Inclusion 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;

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response

Principal Investigator

François CHOMY, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Bergonié

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IB2004-20

NCT ID:

NCT00210171

Start Date:

May 2004

Completion Date:

March 2007

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Stage IIIA Non Small Cell Lung
  • Stage IIIB Non-Small-Cell Lung
  • Concomitant chemo-radiotherapy
  • Consolidation chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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