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Chemoradiotherapy of NSCLC Stage IIIB

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00198432
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 10, 2016
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
NSCLC Stage IIIB Concomitant Radiochemotherapy Drug: Paclitaxel, vinorelbine, cisplatin Phase 2

Detailed 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)


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2002
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Vinorelbine
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Objective response rate

Secondary Outcome Measures :
  1. Overall survival
  2. Time to progression
  3. Relapse rate (local control)
  4. Safety

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198432


Locations
France
CHU Saint-Etienne Pneumologie
Saint-Etienne, France, 42000
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Bristol-Myers Squibb
Pierre Fabre Laboratories
Ligue contre le cancer, France
Investigators
Principal Investigator: Pierre Fournel, Dr IFCT