FDG-PET lung: Predictive Value of FDG-PET-CT Scans for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation

Sponsor

Maastricht Radiation Oncology (Other)

Overall Status

Terminated

CT.gov ID

NCT00522639

Collaborator

Academisch Ziekenhuis Maastricht (Other)

120

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer SCLC NSCLC	Other: 18F-deoxyglucose (FDG)	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Oct 1, 2008

Actual Study Completion Date :

Jun 1, 2009

Outcome Measures

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 [9 months post-radiation]

Secondary Outcome Measures

- Incidence of acute radiation-induced oesophagitis - Incidence of radiation-induced pulmonary toxicity 3 and 9 months post-radiation [9 months post-radiation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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