Rectum CancerNCT00576563
Rectal Study: Value of Repeated FDG-PET-CT Scans in Rectal Cancer
A study testing FDG in people with Rectum Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2007to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- Repetitive FDG-PET-CT scans in order to assess early tumour response monitoring.
- Blood sampling before, during and after radiotherapy in order to find predictors for normal tissue injury and for tumour response.
- Extra staining of tumour biopsies.
- 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.
- Before radiotherapy, 10 millilitres of blood will be taken.
- 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.
- Conditions
- Rectum Cancer
- Being tested
- FDG
- Keywords
- rectal cancer, blood proteins, irradiation, FDG-PET-CT
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDGDrug
Also called Omnipaque 350/ 18 Fluor FDG
contrast medium
| Study group | Role | What they receive |
|---|---|---|
| FDG PET CT | Other | 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. Receives: Drug: FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
Clinical examination(weight, performance status including the CTCv3.0 scale for acute and late reactions)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startMar 2007
- Primary completionJan 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Lammering, MD PHD, Principal investigator, Maastricht Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576563
- Sponsor's protocol ID
- 06-02
- Status last verified
- Apr 2016
- First submitted
- 18 Dec 2007
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00576563
- Acronym / sponsor ID
- 06-02
- Conditions
- Rectum Cancer
- Keywords
- rectal cancer, blood proteins, irradiation, FDG-PET-CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Repetitive FDG-PET-CT scans in order to assess early tumour response monitoring.
- Blood sampling before, during and after radiotherapy in order to find predictors for normal tissue injury and for tumour response.
- Extra staining of tumour biopsies.
- 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.
- Before radiotherapy, 10 millilitres of blood will be taken.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG PET CT | Other | Drug: FDGTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- Not adenocarcinoma histology
- History of prior pelvis radiotherapy
- Recent (< 3 months) myocardial infarction
- Uncontrolled infectious disease
- Less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDGAlso: Omnipaque 350/ 18 Fluor FDGcontrast medium | Drug | FDG PET CT |
Primary outcome
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
1 secondary outcome
Clinical examination(weight, performance status including the CTCv3.0 scale for acute and late reactions)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Lammering, MD PHD principal investigator
Maastricht Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG in people with Rectum Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.