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

April 20, 2016 updated by: Maastricht Radiation Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Maastricht Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FDG PET CT
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: FDG
contrast medium
Other Names:
  • Omnipaque 350/ 18 Fluor FDG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical examination(weight, performance status including the CTCv3.0 scale for acute and late reactions)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht Radiation Oncology

Investigators

  • Principal Investigator: Guido Lammering, MD PHD, Maastricht Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 18, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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