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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00759382
Other study ID # 01071
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2008
Est. completion date January 2022

Study information

Verified date August 2021
Source European Lung Cancer Working Party
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 340
Est. completion date January 2022
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
Belgium 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 CHU Charleroi Charleroi
Belgium Department of Pneumology Hôpital Saint-Joseph Gilly
Belgium Hôpital Ambroise Paré Mons
Belgium Department of Pneumology Centre Hospitalier de Mouscron Mouscron

Sponsors (1)

Lead Sponsor Collaborator
European Lung Cancer Working Party

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other discriminant value of 18F-FDG uptake for survival and for PFS dated from PET examination
Primary Survival Survival will be dated from the date of PET scan
Secondary Progression-free survival Period between the date of PET scan and the date of first progression or death
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