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Predictive Value of FDG-TEP During Radiotherapy (RT) or Chemo-radiotherapy (CRT) in Patients With Non Small Cell Lung Cancer on the One-year Survival (RTEP2)

This study is currently recruiting participants.
Verified April 2013 by Centre Henri Becquerel
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel
ClinicalTrials.gov Identifier:
NCT01261598
First received: November 19, 2010
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

The poor prognosis in the early-stage of lung cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments.

FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after RT or CRT. Our assumption is that an FDG-PET exam during the course of the RT or CRT might be predictive of the treatment efficiency few months later.

In this study, the investigators propose to perform 4 FDG-PET: first "PET1" before radiotherapy, second "PET2" during the radiotherapy (see RTEP1), third and fourth "PET3" "PET4" 3month and 12 month after the therapy.

The investigators will investigate the performances of FDG-PET performed during the RT or CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, the investigators would be able to optimize the planning treatment during the course of the therapy.


Condition Intervention
Lung Cancer
NSCLC
 Procedure: Positron Emission Tomography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Predictive Value of FDG-TEP During Radiotherapy (RT) or Chemo-radiotherapy (CRT) in Patients With Non Small Cell Lung Cancer on the One-year Survival

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Henri Becquerel:

Primary Outcome Measures:
  • SUV max from FDG PETScan [ Time Frame: Baseline - 5 Weeks after begining of radiotherapy- 3 months after end of radiotherapy- 1 year afterwards ] [ Designated as safety issue: No ]
    Measure of FDG-TEP uptake variation (SUV max) to assess predictive value of FDG-TEP during radiotherapy


Secondary Outcome Measures:
  • Study of several optimized radiotherapy scenary according to the quantification of the tumour glucose consumption during radiotherapy [ Time Frame: after the completion enrollment date ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: November 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Patients treated with curative and exclusive radiotherapy (60 Gy minimum), with possibly prior chemotherapy
 Procedure: Positron Emission Tomography
Positron Emission Tomography
Other Name: PET scan
2
Patient treated with concomitant chemotherapy and radiotherapy (60 Gy minimum), with possibly prior chemotherapy chemotherapy Treatment
 Procedure: Positron Emission Tomography
Positron Emission Tomography
Other Name: PET scan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed non-small cell lung cancer
  • Fertile patients must use effective contraception
  • WHO performance status <2
  • Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (≥ 10 mm with spiral CT scan)

Exclusion Criteria:

  • Pregnant or lactating females
  • Baseline fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) scan without any target lesion
  • Unable to under PET CT evaluation
  • other concurrent investigational agents
  • No Planning to undergo curative intent radiotherapy
  • familial, social, geographic, or psychological conditions that would preclude study participation
  • Prior malignancy progressive disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261598

Contacts
Contact: bernard DUBRAY, phD 00.33.02.32.08.25.04 bernard.dubray@rouen.fnclcc.fr
Contact: Agathe Edet-Sanson, MD 00.33.02.32.08.25.50 agaede@rouen.fnclcc.fr

Locations
France
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Contact: Arthur DUMOUCHEL, CRA     00.33.02.32.08.29.61     arthur.dumouchel@rouen.fnclcc.fr    
Contact: Marc THILLAYS, CRA     00.33.02.32.08.24.97     marc.thillays@rouen.fnclcc.fr    
Principal Investigator: Agathe Edet-Sanson, MD            
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
Principal Investigator: Bernard DUBRAY, phD Centre Henri Becquerel
  More Information

No publications provided

Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT01261598     History of Changes
Other Study ID Numbers: CHB06-02
Study First Received: November 19, 2010
Last Updated: April 15, 2013
Health Authority: France: Institutional Ethical Committee

Keywords provided by Centre Henri Becquerel:
Positron-Emission Tomography
PET Scan
Non-Small-Cell Lung Carcinoma
Radiation Oncology
SUV

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013