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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

18 Years
Open (Enrolling)
Rectum Cancer

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Guido Lammering, MD PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maastricht Radiation Oncology


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

Study ID:




Start Date:

March 2007

Completion Date:

March 2014

Related Keywords:

  • Rectum Cancer
  • rectal cancer
  • blood proteins
  • irradiation
  • Rectal Neoplasms