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

Lung Cancer Clinical Trial

— RTEP2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261598
• Other study ID #: CHB06-02
• Status: Completed
• Phase: N/A
• First received: November 19, 2010
• Last updated: October 14, 2016
• Start date: November 2007
• Est. completion date: December 2013

Study information

• Verified date: October 2016
• Source: Centre Henri Becquerel
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• NSCLC

Intervention

Procedure:
• Positron Emission Tomography
Positron Emission Tomography

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUV max from FDG PETScan	Measure of FDG-TEP uptake variation (SUV max) to assess predictive value of FDG-TEP during radiotherapy	Baseline - 5 Weeks after begining of radiotherapy- 3 months after end of radiotherapy- 1 year afterwards	No
Secondary	Study of several optimized radiotherapy scenary according to the quantification of the tumour glucose consumption during radiotherapy		after the completion enrollment date	No