- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00198432
Chemoradiotherapy of NSCLC Stage IIIB
March 9, 2016 updated by: Intergroupe Francophone de Cancerologie Thoracique
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
130
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Saint-Etienne, France, 42000
- CHU Saint-Etienne Pneumologie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Objective response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Time to progression
|
Overall survival
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Safety
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Relapse rate (local control)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pierre Fournel, Dr, Intergroupe Francophone de Cancerologie Thoracique
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
March 10, 2016
Last Update Submitted That Met QC Criteria
March 9, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
- Vinorelbine
Other Study ID Numbers
- IFCT-0201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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