Study Stopped
Poor accrual
Predictive Value of FDG-PET-CT Scans for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation
FDG-PET lung
Determination of the Predictive Value of FDG-PET-CT Scans, Blood Proteins and Blood Cells for the Prognosis for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation
2 other identifiers
interventional
120
1 country
1
Brief Summary
The objective of the study is to investigate the evolution ofn 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with lung cancer of during and after concurrent radiotherapy and chemotherapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 lung-cancer
Started Oct 2008
Shorter than P25 for phase_3 lung-cancer
1 active site
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
First Submitted
Initial submission to the registry
August 29, 2007
CompletedFirst Posted
Study publicly available on registry
August 30, 2007
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJune 30, 2009
June 1, 2009
August 29, 2007
June 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumour response, measured with FDG-PET-CT scans 3 months post-radiation. as a function of delta FDG uptake the first week during radiotherapy
9 months post-radiation
Secondary Outcomes (1)
- Incidence of acute radiation-induced oesophagitis - Incidence of radiation-induced pulmonary toxicity 3 and 9 months post-radiation
9 months post-radiation
Interventions
contrast medium
Eligibility Criteria
You may qualify if:
- Histological proven non-small cell or small cell lung cancer UICC stage I-III (in case of small cell lung cancer: limited stage)
- WHO performance status 0-2
- Less than 10 % weight loss the last 6 months
- In case of previous chemotherapy, concurrent chemo-radiotherapy can start after a minimum of 21 days after the last chemotherapy course
- No recent (\< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
- No active peptic oesophagitis
- Life expectancy more than 6 months
- Measurable cancer
- Willing and able to comply with the study prescriptions
- years or older
- Not pregnant and willing to take adequate contraceptive measures during the study
- Have given written informed consent before patient registration
- No previous radiotherapy to the chest
You may not qualify if:
- Not non-small cell or small cell histology, e.g. mesothelioma, lymphoma
- Malignant pleural or pericardial effusion
- History of prior chest radiotherapy
- Recent (\< 3 months) myocardial infarction
- Uncontrolled infectious disease
- Distant metastases (stage IV)
- Patients with active peptic oesophagitis in the last year
- Less than 18 years old
- Pregnant or not willing to take adequate contraceptive measures during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht Radiation Oncologylead
- Academisch Ziekenhuis Maastrichtcollaborator
Study Sites (1)
Maastricht Radiation Oncology, MAASTRO
Maastricht, Limburg, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dirk De Ruysscher, MD PhD
MAASTRO, Maastricht Radiation Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 29, 2007
First Posted
August 30, 2007
Study Start
October 1, 2008
Study Completion
June 1, 2009
Last Updated
June 30, 2009
Record last verified: 2009-06