Predictive Value of FDG-PET-CT Scans for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation (FDG-PET lung)
Primary Purpose
Lung Cancer, SCLC, NSCLC
Status
Terminated
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
18F-deoxyglucose (FDG)
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring lung cancer, FDG-PET-CT, blood proteins, prognose
Eligibility Criteria
Inclusion Criteria:
- 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
- 18 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
Exclusion Criteria:
- 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
Sites / Locations
- Maastricht Radiation Oncology, MAASTRO
Outcomes
Primary Outcome Measures
Tumour response, measured with FDG-PET-CT scans 3 months post-radiation. as a function of delta FDG uptake the first week during radiotherapy
Secondary Outcome Measures
- Incidence of acute radiation-induced oesophagitis - Incidence of radiation-induced pulmonary toxicity 3 and 9 months post-radiation
Full Information
NCT ID
NCT00522639
First Posted
August 29, 2007
Last Updated
June 29, 2009
Sponsor
Maastricht Radiation Oncology
Collaborators
Academisch Ziekenhuis Maastricht
1. Study Identification
Unique Protocol Identification Number
NCT00522639
Brief Title
Predictive Value of FDG-PET-CT Scans for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation
Acronym
FDG-PET lung
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
October 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht Radiation Oncology
Collaborators
Academisch Ziekenhuis Maastricht
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
This translational research part is aiming to give more insights in the way radiation injury and tumour response develops.
It involves three parts:
Repetitive FDG-PET-CT scans in order to assess early tumour response monitoring.
Blood sampling before, during and after radiotherapy in order to find predictors for normal tissue injury and for tumour response.
Extra staining of tumour biopsies
The FDG-PET-CT scan with i.v. contrast gives information of the tumour metabolism and its morphology. Therefore, one extra FDG-PET-CT scans will be done during radiotherapy at day 8. Tumour response will be determined by FDG-PET-CT scans 3 months after radiotherapy.
Blood samples
Before radiotherapy, 12 millilitres of blood (EDTA tubes) will be taken according to serum protocol (appendix 5).
At day 7, day 14 during concurrent chemo-radiation, 7 days after the end of this treatment and 3 months and 9 months after the end of radiotherapy, 12 millilitres serum (EDTA tube) will be taken to investigate the evolution of the proteins [In the first place, plasma concentrations of osteopontin and soluble CA9 for hypoxia, CRP and IL-6 for inflammation, total and free VEGF for angiogenesis and total and cleaved cytokeratin 18 for necrosis/apoptosis will be determined] during and after treatment, for its kinetics may be important as predictive factors. Standard ELISA tests will be used to determine these levels.
Before radiotherapy, at day 7 and at day 14 during radiation, 7 days after the end of this treatment and 3 months and 9 months after the end of radiotherapy, 24 millilitres of blood (EDTA tubes) will be taken to investigate the evolution of circulating cells and their progenitors during and after treatment.
The tumour biopsies may be stained with markers for proliferation (e.g. KI 67), apoptosis (e.g. M30), hypoxia (e.g. CA 9, Glut 1 and 3) and others (e.g. EGFR and EGFRvIII), in order to correlate these measurements with response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, SCLC, NSCLC
Keywords
lung cancer, FDG-PET-CT, blood proteins, prognose
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
18F-deoxyglucose (FDG)
Intervention Description
contrast medium
Primary Outcome Measure Information:
Title
Tumour response, measured with FDG-PET-CT scans 3 months post-radiation. as a function of delta FDG uptake the first week during radiotherapy
Time Frame
9 months post-radiation
Secondary Outcome Measure Information:
Title
- Incidence of acute radiation-induced oesophagitis - Incidence of radiation-induced pulmonary toxicity 3 and 9 months post-radiation
Time Frame
9 months post-radiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
18 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk De Ruysscher, MD PhD
Organizational Affiliation
MAASTRO, Maastricht Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht Radiation Oncology, MAASTRO
City
Maastricht
State/Province
Limburg
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Predictive Value of FDG-PET-CT Scans for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation
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