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

This study has been terminated.
(Poor accrual)
Sponsor:
Collaborator:
Academisch Ziekenhuis Maastricht
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00522639
First received: August 29, 2007
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

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 Intervention Phase
Lung Cancer
SCLC
NSCLC
Other: 18F-deoxyglucose (FDG)
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

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 [ Time Frame: 9 months post-radiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Incidence of acute radiation-induced oesophagitis - Incidence of radiation-induced pulmonary toxicity 3 and 9 months post-radiation [ Time Frame: 9 months post-radiation ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2008
Study Completion Date: June 2009
Intervention Details:
    Other: 18F-deoxyglucose (FDG)
    contrast medium
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:

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522639

Locations
Netherlands
Maastricht Radiation Oncology, MAASTRO
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
Maastricht Radiation Oncology
Academisch Ziekenhuis Maastricht
Investigators
Principal Investigator: Dirk De Ruysscher, MD PhD MAASTRO, Maastricht Radiation Oncology
  More Information

No publications provided

Responsible Party: Dr. D.K.M. De Ruysscher, MAASTRO clinic
ClinicalTrials.gov Identifier: NCT00522639     History of Changes
Other Study ID Numbers: 06-02-117, TACIR
Study First Received: August 29, 2007
Last Updated: June 29, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
lung cancer
FDG-PET-CT
blood proteins
prognose

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Deoxyglucose
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014