NCT00759382

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

12.5 years

First QC Date

September 24, 2008

Last Update Submit

August 20, 2021

Conditions

Non Small Cell Lung Carcinoma

Keywords

Non small cell lung carcinomaPET scanObservational studyNon metastatictreatedcurative intent

Outcome Measures

Primary Outcomes (1)

  • Survival

    Survival will be dated from the date of PET scan

Secondary Outcomes (1)

  • Progression-free survival

    Period between the date of PET scan and the date of first progression or death

Other Outcomes (1)

  • discriminant value of 18F-FDG uptake for survival and for PFS

    dated from PET examination

Study Arms (1)

I

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presenting with non metastatic non small cell lung carcinoma, treated in the participating centres with curative intent

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Pneumology RHMS Hôpital de la Madeleine

Ath, 7800, Belgium

Location

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, 1000, Belgium

Location

Department of Pneumology CHU Charleroi

Charleroi, 6000, Belgium

Location

Department of Pneumology Hôpital Saint-Joseph

Gilly, 6060, Belgium

Location

Hôpital Ambroise Paré

Mons, 7000, Belgium

Location

Department of Pneumology Centre Hospitalier de Mouscron

Mouscron, 7700, Belgium

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Thierry Berghmans, MD

    European Lung Cancer Working Party

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations

BE(6)