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Chemoradiotherapy of NSCLC Stage IIIB

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pierre Fabre Laboratories
Ligue contre le cancer, France
Information provided by:
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00198432
First received: September 13, 2005
Last updated: December 23, 2005
Last verified: December 2005

September 13, 2005
December 23, 2005
March 2002
Not Provided
Objective response rate
Same as current
Complete list of historical versions of study NCT00198432 on ClinicalTrials.gov Archive Site
  • Overall survival
  • Time to progression
  • Relapse rate (local control)
  • Safety
Same as current
Not Provided
Not Provided
 
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

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)

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • NSCLC Stage IIIB
  • Concomitant Radiochemotherapy
Drug: Paclitaxel, vinorelbine, cisplatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
December 2006
Not Provided

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

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00198432
IFCT-0201
Not Provided
Not Provided
Intergroupe Francophone de Cancerologie Thoracique
  • Bristol-Myers Squibb
  • Pierre Fabre Laboratories
  • Ligue contre le cancer, France
Principal Investigator: Pierre Fournel, Dr IFCT
Intergroupe Francophone de Cancerologie Thoracique
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP