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Completed

NCT Number: NCT01261598

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

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms NSCLC Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Henri Becquerel

Rouen, 76000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positron Emission Tomography

Procedure

Positron Emission Tomography

Other names: PET scan

Primary outcomes

  1. 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 outcomes

  1. Study of several optimized radiotherapy scenary according to the quantification of the tumour glucose consumption during radiotherapy

    Time frame: after the completion enrollment date

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study 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

Acronym: RTEP2

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Dec 16, 2010
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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