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Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable


Phase 2
18 Years
70 Years
Not Enrolling
Both
NSCLC Stage IIIB, Concomitant Radiochemotherapy

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Trial Information

Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable


Chemotherapy:

C = Cisplatine : 80 mg/m² P = Paclitaxel : 200 mg/m² N = Vinorelbine : 15 mg/m²

Radiotherapy:

66 Gy with 33 fractions (2 Gy/fraction, 1 fraction/day, 6,5 weeks) High energy Photons X (>=
9MV)


Inclusion Criteria:



- NSCLC stage IIIA N2 or IIIB not resectable, except N3 sus-clavicular, nor reached
pleural

- PS = 0 or 1

- Possibility of including all the targets in only one exposure field

- Slimming < 10% of the weight of the body

- Functions hepatic, renal and hematologic normal

- VEMS >40% and PaO2 >60 mmHg

- written and signed informed consent

Exclusion criteria :

- NSCLC stage IV or wet-IIIB

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Principal Investigator

Pierre Fournel, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

IFCT

Authority:

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

Study ID:

IFCT-0201

NCT ID:

NCT00198432

Start Date:

March 2002

Completion Date:

December 2006

Related Keywords:

  • NSCLC Stage IIIB
  • Concomitant Radiochemotherapy
  • Carcinoma, Non-Small-Cell Lung

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