Trial | NCT00198432  Report issue

Title

Chemoradiotherapy of NSCLC Stage IIIB
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

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    130
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.
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)
Study Started
Mar 31
2002
Study Completion
Dec 31
2006
Last Update
Mar 10
2016
Estimate

Drug Paclitaxel, vinorelbine, cisplatin

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
No Results Posted