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.

European Lung Cancer Working Party

Status: Unknown

Conditions: Non Small Cell Lung Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT00759382

01071

Details and patient eligibility

About

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).

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

340 participants in 1 patient group

I

Description:

Patients with non-small cell lung carcinoma treated with curative intent