Rectal Study: Value of Repeated FDG-PET-CT Scans in Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Maastricht Radiation Oncology.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00576563
First received: December 18, 2007
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with rectal cancer during and after radiotherapy or combined radiotherapy and chemotherapy.

The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response.

Study hypothesis The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response.


Condition Intervention
Rectum Cancer
Drug: Omnipaque 350/ 18 Fluor FDG

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rectal Cancer: Determination of the Predictive Value by Use of FDG-PET-CT Scans and Blood Proteins for the Prognosis of Patients With Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • The metabolic tumour response by PET scan will be determined according to the EORTC criteria (appendix 1)61. The pathological tumour response will be determined according to Dworak and Wheeler.62,63 [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical examination(weight, performance status including the CTCv3.0 scale for acute and late reactions) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2007
Estimated Study Completion Date: March 2014
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with rectal cancer during and after radiotherapy or combined radiotherapy and chemotherapy.
Drug: Omnipaque 350/ 18 Fluor 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.

1. FDG-PET-CT scans The FDG-PET-CT scan with i.v. contrast gives information of the tumour metabolism and its morphology. The pre-treatment max SUV is prognostic as a high value confers a worse prognosis. Our group showed both in vitro and in vivo that a high FDG uptake is due to tumour hypoxia. The evolution of the max SUV during radiotherapy may thus be predictive for the ultimate tumour response. Therefore, two extra FDG-PET-CT scans will be done during radiotherapy for the group of patients receiving long-term radiochemotherapy: one at day 7 and one at day 14. This will enable calculation of the max SUV kinetics during treatment. Tumour response will be determined by FDG-PET-CT scans 3-5 days after the short- course of radiotherapy or 6-8 weeks after the long- term radiochemotherapy.

2 Blood samples Blood collection and processing before, during and after radiotherapy will be done according to the serum protocol. For performing ELISA's blood samples should be collected and put in the freezer. The analysis of all blood material will be performed months to years after collection and re-analysis with regard to the described protein groups may be necessary depending on the outcome.

  1. Before radiotherapy, 10 millilitres of blood will be taken.
  2. At day 7, day 14 and 6-8 weeks after the end of radiotherapy for the long- term radiotherapy or 3-5 days after the short - course of radiotherapy,i.e. at the same days that the FDG-PET-CT scans will be performed, 10 millilitres serum (EDTA tube) will be taken to investigate the evolution of the proteins during and after treatment, for its kinetics may be important as predictive factors.

3 Extra staining of tumour biopsies The tumour biopsies may be stained with markers for proliferation (e.g. KI 67), apoptosis (e.g. M30), hypoxia (e.g. HIF, 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 rectal cancer
  • UICC stage I-IV
  • WHO performance status 0-2
  • Less than 10 % weight loss in the last 6 months
  • In case of previous chemotherapy, 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)
  • 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 pelvis

Exclusion Criteria:

  • Not adenocarcinoma histology
  • History of prior pelvis radiotherapy
  • Recent (< 3 months) myocardial infarction
  • Uncontrolled infectious disease
  • Less than 18 years old
  • Pregnant or not willing to take adequate contraceptive measures during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576563

Locations
Netherlands
Maatricht Radiation Oncology
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: Guido Lammering, MD PHD Maastricht Radiation Oncology
  More Information

No publications provided

Responsible Party: G.Lammering, MD, PhD, MAASTRO clinic
ClinicalTrials.gov Identifier: NCT00576563     History of Changes
Other Study ID Numbers: 06-02
Study First Received: December 18, 2007
Last Updated: April 19, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
rectal cancer
blood proteins
irradiation
FDG-PET-CT

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014