Colorectal Cancer MetastaticearlyPETmCRCNCT00741481
PET Evaluation of Response After 1 Course of Chemotherapy as Predictor of Treatment Outcome.
An observational study of Colorectal Cancer Metastatic and Early Response Evaluation, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
Study hypothesis : early decrease in fdg-pet measured SUV max after 1 cycle of chemotherapy can accurately predict response of chemotherapy as assessed by conventional radiology after 3 cycles of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Early Response Evaluation, Fdg-PET
- What is being tested?
- FDG-PET imaging
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2006to Jul 2010
- Phase
- Observational
- 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
Study population: Patients >18 yrs old advanced evaluable colorectal cancer beginning a new line of chemotherapy
Who may be able to join
- advanced colorectal cancer
- evaluable disease
- signed informed consent
Who cannot join
- no other cancer
- no other life-threatening condition
- unwillingness or inability to sign informed consent
- active cerebral metastasis
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Institut Jules Bordet, Université Libre de Bruxelles
Brussels, 1190
About this study
Official title: Evaluation of Prognostic and Predictive Value of PETSCAn in ColoRectal Cancer (CRC)
Study hypothesis : early decrease in fdg-pet measured SUV max after 1 cycle of chemotherapy can accurately predict response of chemotherapy as assessed by conventional radiology after 3 cycles of chemotherapy.
FDG-PET imaging will be done at J0 and J14 of a new line of chemotherapy treatment in metastatic colorectal cancer.
SUV max will be recorded and delta SUVmax will be compared to the results of conventional radiological evaluation after 3 courses of chemotherapy. Results will also be compared to the time to disease progression.
Read the detailed description
statistical hypothesis : Sample size calculation for FDG-PET in metastatic patients.
In the paper of Cascini et al. [1], they have 18 patients with a TRG response (TRG = Tumor Regression Grade) and 15 patients with no response.
SUV mean was measured at baseline and at day 12 in all 33 patients. All 33 patients showed a reduction in SUV-mean from baseline to day 12. The median reduction in SUV-mean was 63% (mean 66%) in responding tumors and 22% (mean 22%) for non responding tumors. Using a cutoff level of 52% a perfect accuracy could be obtained, i.e. all responding tumors had a SUV-mean reduction higher than 52% and all non responding tumors had a SUV-mean reduction lower than 52%.
(Standard deviation of the SUV-mean reduction was 25.) All 33 patients showed also a reduction in SUV-max from baseline to day 12. The median reduction in SUV-max was 62% in responding tumors and 28% in non responding tumors. (No information about mean or standard deviation of SUV-max available in [1].) Based on the data of SUV-mean we can do a power calculation based on the Wilcoxon test: In order to demonstrate an absolute difference in the mean of ΔSUV-mean of 44% between responding and non responding patients, with an estimated standard deviation of 25, using 35 patients (50% response, 50% no response), at a significance level of 5%, we obtain a power of 0.98.
For SUV-max, if we assume that the difference in the means is similar to the difference in the medians, i.e. 34% and the standard deviation is similar to the one of SUV-mean, i.e. 25, we obtain a power of 0.93 If we, to be safe, are a little bit less optimistic and estimate that the difference in the mean of ΔSUV-max between responding and non responding tumors would be a little lower than in [1]: 35%, and the standard deviation a little bit higher: 30, then we need 40 patients at a power of 0.90
Référence 1 : Cascini GL, Avallone A, Delrio P, Guida C, Tatangelo F, Marone P et al.: F-18-FDG PET is an early predictor of pathologic tumor response to preoperative radiochemotherapy in locally advanced rectal cancer. Journal of Nuclear Medicine 2006, 47: 1241-1248.
- Being tested
- FDG-PET imaging
- Keywords
- metastatic colorectal cancer, fdg pet, response evaluation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PET imagingProcedure or surgery
Also called PET-CT SCan
FDG-PET imaging at D0 and D14 of first course of a new chemotherapy for advanced colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| 1 | all study population Receives: Procedure: FDG-PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare fdg-pet variations after 1 course of chemotherapy to chemotherapy outcome measured by time to disease progression
Measured: Time to Disease progression
Secondary outcomes (1)
compare fdg-pet variations after 1 course of chemotherapy to chemotherapy outcome measured by tumour response rate following RECIST criteria.
Measured: response rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startJun 2006
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Investigators
- Alain - Hendlisz, MD, Principal investigator, Institut Jules Bordet, Université Libre de Bruxelles, Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741481
- Sponsor's protocol ID
- earlyPETmCRC
- Other IDs
- comité éthique IJB n° 1377
- Acronym
- earlyPETmCRC
- Status last verified
- Feb 2011
- First submitted
- 25 Aug 2008
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prognostic and Predictive Value of PETSCAn in ColoRectal Cancer (CRC)
- ClinicalTrials.gov ID
- NCT00741481
- Acronym / sponsor ID
- earlyPETmCRC / earlyPETmCRC
- Keywords
- metastatic colorectal cancer, fdg pet, response evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Aug 2008 (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.
Study hypothesis : early decrease in fdg-pet measured SUV max after 1 cycle of chemotherapy can accurately predict response of chemotherapy as assessed by conventional radiology after 3 cycles of chemotherapy.
FDG-PET imaging will be done at J0 and J14 of a new line of chemotherapy treatment in metastatic colorectal cancer.
SUV max will be recorded and delta SUVmax will be compared to the results of conventional radiological evaluation after 3 courses of chemotherapy. Results will also be compared to the time to disease progression.
Detailed description
statistical hypothesis : Sample size calculation for FDG-PET in metastatic patients.
In the paper of Cascini et al. [1], they have 18 patients with a TRG response (TRG = Tumor Regression Grade) and 15 patients with no response.
SUV mean was measured at baseline and at day 12 in all 33 patients. All 33 patients showed a reduction in SUV-mean from baseline to day 12. The median reduction in SUV-mean was 63% (mean 66%) in responding tumors and 22% (mean 22%) for non responding tumors. Using a cutoff level of 52% a perfect accuracy could be obtained, i.e. all responding tumors had a SUV-mean reduction higher than 52% and all non responding tumors had a SUV-mean reduction lower than 52%.
(Standard deviation of the SUV-mean reduction was 25.) All 33 patients showed also a reduction in SUV-max from baseline to day 12. The median reduction in SUV-max was 62% in responding tumors and 28% in non responding tumors. (No information about mean or standard deviation of SUV-max available in [1].) Based on the data of SUV-mean we can do a power calculation based on the Wilcoxon test: In order to demonstrate an absolute difference in the mean of ΔSUV-mean of 44% between responding and non responding patients, with an estimated standard deviation of 25, using 35 patients (50% response, 50% no response), at a significance level of 5%, we obtain a power of 0.98.
For SUV-max, if we assume that the difference in the means is similar to the difference in the medians, i.e. 34% and the standard deviation is similar to the one of SUV-mean, i.e. 25, we obtain a power of 0.93 If we, to be safe, are a little bit less optimistic and estimate that the difference in the mean of ΔSUV-max between responding and non responding tumors would be a little lower than in [1]: 35%, and the standard deviation a little bit higher: 30, then we need 40 patients at a power of 0.90
Référence 1 : Cascini GL, Avallone A, Delrio P, Guida C, Tatangelo F, Marone P et al.: F-18-FDG PET is an early predictor of pathologic tumor response to preoperative radiochemotherapy in locally advanced rectal cancer. Journal of Nuclear Medicine 2006, 47: 1241-1248.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: FDG-PET imagingall study population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >18 yrs old advanced evaluable colorectal cancer beginning a new line of chemotherapy
Key inclusion criteria (3 listed)
- advanced colorectal cancer
- evaluable disease
- signed informed consent
Key exclusion criteria (4 listed)
- no other cancer
- no other life-threatening condition
- unwillingness or inability to sign informed consent
- active cerebral metastasis
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 |
|---|---|---|
| FDG-PET imagingAlso: PET-CT SCanFDG-PET imaging at D0 and D14 of first course of a new chemotherapy for advanced colorectal cancer | Procedure or surgery | 1 |
Primary outcome
compare fdg-pet variations after 1 course of chemotherapy to chemotherapy outcome measured by time to disease progression
Time frame: Time to Disease progression
1 secondary outcome
compare fdg-pet variations after 1 course of chemotherapy to chemotherapy outcome measured by tumour response rate following RECIST criteria.
Time frame: response rate
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 24 Feb 2011.
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CRC
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.
Alain - Hendlisz, MD principal investigator
Institut Jules Bordet, Université Libre de Bruxelles, Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic and Early Response Evaluation, run by Jules Bordet Institute at 1 site in Belgium.
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 3 inclusion and 4 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 24 Feb 2011. 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 Belgium. 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?
compare fdg-pet variations after 1 course of chemotherapy to chemotherapy outcome measured by time to disease progression (time frame: Time to Disease progression). 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 24 Feb 2011.