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

Not Applicable

Completed

• Conditions: Lung Cancer; NSCLC
• Interventions: Procedure: Positron Emission Tomography

• Registration Number: NCT01261598
• Lead Sponsor: Centre Henri Becquerel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Positron Emission Tomography	Patients treated with curative and exclusive radiotherapy (60 Gy minimum), with possibly prior chemotherapy
2	Positron Emission Tomography	Patient treated with concomitant chemotherapy and radiotherapy (60 Gy minimum), with possibly prior chemotherapy chemotherapy Treatment

Primary Outcome Measures

Name	Time	Method
SUV max from FDG PETScan	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

Name	Time	Method
Study of several optimized radiotherapy scenary according to the quantification of the tumour glucose consumption during radiotherapy	after the completion enrollment date

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France