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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01261598
Acronym
RTEP2
Enrollment
98
Registered
2010-12-16
Start date
2007-11-30
Completion date
2013-12-31
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, NSCLC

Keywords

Positron-Emission Tomography, PET Scan, Non-Small-Cell Lung Carcinoma, Radiation Oncology, SUV

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.

Interventions

PROCEDUREPositron Emission Tomography

Positron Emission Tomography

Sponsors

Centre Henri Becquerel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
SUV max from FDG PETScanBaseline - 5 Weeks after begining of radiotherapy- 3 months after end of radiotherapy- 1 year afterwardsMeasure of FDG-TEP uptake variation (SUV max) to assess predictive value of FDG-TEP during radiotherapy

Secondary

MeasureTime frame
Study of several optimized radiotherapy scenary according to the quantification of the tumour glucose consumption during radiotherapyafter the completion enrollment date

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026