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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer, SCLC, NSCLC

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Trial Information

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


This translational research part is aiming to give more insights in the way radiation injury
and tumour response develops.

It involves three parts:

1. Repetitive FDG-PET-CT scans in order to assess early tumour response monitoring.

2. Blood sampling before, during and after radiotherapy in order to find predictors for
normal tissue injury and for tumour response.

3. 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

1. Before radiotherapy, 12 millilitres of blood (EDTA tubes) will be taken according to
serum protocol (appendix 5).

2. 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.

3. 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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Tumour response, measured with FDG-PET-CT scans 3 months post-radiation. as a function of delta FDG uptake the first week during radiotherapy

Outcome Time Frame:

9 months post-radiation

Safety Issue:

No

Principal Investigator

Dirk De Ruysscher, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MAASTRO, Maastricht Radiation Oncology

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

06-02-117

NCT ID:

NCT00522639

Start Date:

October 2008

Completion Date:

June 2009

Related Keywords:

  • Lung Cancer
  • SCLC
  • NSCLC
  • lung cancer
  • FDG-PET-CT
  • blood proteins
  • prognose
  • Lung Neoplasms

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