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.

• Conditions: Non Small Cell Lung Carcinoma

• Registration Number: NCT00759382
• Lead Sponsor: European Lung Cancer Working Party

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2021-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-23
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	Survival will be dated from the date of PET scan

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Period between the date of PET scan and the date of first progression or death

Trial Locations

Locations (6)

Department of Pneumology RHMS Hôpital de la Madeleine; 🇧🇪 Ath, Belgium

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Department of Pneumology Hôpital Saint-Joseph; 🇧🇪 Gilly, Belgium

Hôpital Ambroise Paré; 🇧🇪 Mons, Belgium

Department of Pneumology CHU Charleroi; 🇧🇪 Charleroi, Belgium

Department of Pneumology Centre Hospitalier de Mouscron; 🇧🇪 Mouscron, Belgium