Clinical trial NCT00759382: Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.
Official title: Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Carcinoma
Keywords: Non small cell lung carcinoma
PET scan
Observational study
Non metastatic
treated
curative intent
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting with non metastatic non small cell lung carcinoma, treated in the participating centres with curative intent

Brief summary: The primary aim of this non interventional study is to assess the independent prognostic role on overall survival of primary tumour 18F-FDG uptake value (SUVmax) measured on 18fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in patients with non-metastatic non-small cell lung cancers treated with curative intent, taking into account the other conventional prognostic factors (performance status, age, sex, disease stage).


Eligibility criteria: Inclusion Criteria:

* Pathologically demonstrated NSCLC
* Stage I-III treated by curative treatment by surgery with or without chemotherapy (induction or adjuvant) or by chemoradiotherapy
* Inoperable patients treated by exclusive radiotherapy
* A whole-body (skull base to mid thighs) FDG-PET or a combined FDG-PET/CT on a dedicated machine, performed before any anticancer treatment
* FDG-PET or combined FDG-PET/CT has to be previously standardised according to the procedure described in appendix IV
* Written informed consent
* Accessibility to follow-up
* Age \> 18 years

Exclusion Criteria:

* Prior anticancer treatment (surgery, radiotherapy or chemotherapy)
* Stage IV NSCLC
* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
* Uncontrolled diabetes mellitus (fast glycaemia above 130 mg/dl)
* Pregnancy and lactating woman
* Unavailability to send a copy of the PET or PET-CT (DICOM format) to the data centre

Primary outcomes:
measure: Survival
timeFrame: Survival will be dated from the date of PET scan
Secondary outcomes:
measure: Progression-free survival
timeFrame: Period between the date of PET scan and the date of first progression or death
Other outcomes:
measure: discriminant value of 18F-FDG uptake for survival and for PFS
timeFrame: dated from PET examination
Locations:
city: Ath
country: Belgium
facility: Department of Pneumology RHMS Hôpital de la Madeleine
city: Brussels
country: Belgium
facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
city: Charleroi
country: Belgium
facility: Department of Pneumology CHU Charleroi
city: Gilly
country: Belgium
facility: Department of Pneumology Hôpital Saint-Joseph
city: Mons
country: Belgium
facility: Hôpital Ambroise Paré
city: Mouscron
country: Belgium
facility: Department of Pneumology Centre Hospitalier de Mouscron
Study officials:
affiliation: European Lung Cancer Working Party
name: Thierry Berghmans, MD
role: STUDY_CHAIR
References: