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Chemoradiotherapy of NSCLC Stage IIIB

I

Intergroupe Francophone de Cancerologie Thoracique

Status and phase

Completed
Phase 2

Conditions

Concomitant Radiochemotherapy
NSCLC Stage IIIB

Treatments

Drug: Paclitaxel, vinorelbine, cisplatin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00198432
IFCT-0201

Details and patient eligibility

About

To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.

Full description

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)

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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