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Predictive Value of FDG-TEP During Radiotherapy or Chemo-radiotherapy in Patients With NCSC on the One-year Survival (RTEP2)

This study has been completed.
Information provided by (Responsible Party):
Centre Henri Becquerel Identifier:
First received: November 19, 2010
Last updated: October 14, 2016
Last verified: October 2016

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
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:

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 ]
    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 ]

Enrollment: 98
Study Start Date: November 2007
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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


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

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
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Please refer to this study by its identifier: NCT01261598

Centre Henri Becquerel
Rouen, France, 76000
Sponsors and Collaborators
Centre Henri Becquerel
Principal Investigator: Bernard DUBRAY, phD Centre Henri Becquerel
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Centre Henri Becquerel Identifier: NCT01261598     History of Changes
Other Study ID Numbers: CHB06-02
Study First Received: November 19, 2010
Last Updated: October 14, 2016
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on April 28, 2017