Colorectal CancerPhase 3PETCAMNCT00265356
Impact of Positron Emission Tomography Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases
A Phase 3 study testing PET diagnostic imaging in people with Colorectal Cancer and Liver Metastases, run by Ontario Clinical Oncology Group (OCOG) at 9 sites in Canada.
Trial summary
The purpose of this trial is to improve the management of patients with potentially surgically curable colorectal cancer liver metastases. The primary objective is to determine the impact of pre-operative positron emission tomography (PET) on patients who have been assessed as having resectable colorectal cancer liver… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- What is being tested?
- PET diagnostic imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 9 sitesCanada
- Study dates
- Nov 2005to Apr 2013
- Phase
- Phase 3
- 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
- Histologic proof of previous colorectal adenocarcinoma (not carcinoid, squamous cell cancer, gastrointestinal stromal tumor, or lymphoma)
- Contrast-enhanced spiral CT scan of the thorax, and a tri-phasic CT scan of the abdomen and pelvis performed within 30 days (plus up to 14 days) before randomization demonstrating resectable metastasis(es) that are isolated to the liver
- Full colonoscopy performed within the preceding 18 months showing no evidence of malignancy (other than a synchronous colorectal primary expected to be removed at time of liver resection)
- Age over 18 years
Who cannot join
- Extrahepatic disease including enlarged portal lymph nodes on CT
- Prior liver resection
- Previous radiofrequency ablation of malignant liver lesion
- Systemic chemotherapy within three weeks prior to randomization
- Radiotherapy within two months prior to randomization
- Significant concurrent medical problems (e.g., uncontrolled diabetes, active cardiac disease, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
Show all 10Show fewer
- Pregnant or lactating female
- Unable to lie supine for imaging with PET
- Previously treated cancer other than non-melanocytic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater
- Patients who, at the time of the initial evaluation, have already undergone a whole body PET within 6 months prior to randomization
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3
London Health Sciences
London, Ontario, N6A 5A5
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
University Health Network
Toronto, Ontario, M5G 1X5
St. Joseph's Health Centre
Toronto, Ontario, M6R 1B5
About this study
Official title: The Impact of Positron Emission Tomography (PET) Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases: A Prospective, Multicentre Randomized Clinical Trial
The purpose of this trial is to improve the management of patients with potentially surgically curable colorectal cancer liver metastases.
The primary objective is to determine the impact of pre-operative positron emission tomography (PET) on patients who have been assessed as having resectable colorectal cancer liver metastases by conventional imaging (computed tomography (CT) abdomen/thorax, colonoscopy), by determining the proportion of patients who have a change in management resulting from PET.
Read the detailed description
Colorectal cancer remains a leading cause of death in men and women. A significant number of patients with colorectal cancer will either present with, or subsequently develop, liver metastases. In contrast to many other epithelial solid tumours, resection of colorectal cancer hepatic metastases results in long-term survival and even cure. However, despite state of the art CT imaging, 60-75% of patients who appear to have limited disease amenable to surgical resection will eventually die from extra-hepatic and recurrent hepatic metastases. If occult micrometastatic disease that becomes evident after liver resection could be detected reliably during pre-operative assessment, patients harboring more widespread disease could be spared a non-curative liver resection. This is one of the present challenges of liver surgery. PET imaging has the potential to improve the detection of both hepatic and extra-hepatic metastatic disease, not detected by conventional imaging modalities.
This prospective, multicenter trial will enroll patients with colorectal cancer liver metastases considered resectable, based on CT scans of the thorax, abdomen and pelvis, which demonstrate no evidence of extra-hepatic disease. A full colonoscopy within the preceding 12 months will ensure there is no local recurrence, or other primary cancer at the time of planned liver resection. These patients will be randomized to PET scan or not.
- Conditions
- Colorectal Cancer, Liver Metastases
- Being tested
- PET diagnostic imaging
- Keywords
- Positron Emission Tomography (PET), Diagnostic Investigation, Colorectal cancer, Liver metastases, Liver surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET diagnostic imagingProcedure or surgery
Also called Positron Emission Tomography
PET diagnostic imaging
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PET diagnostic imaging Receives: Procedure: PET diagnostic imaging |
| 2 | No intervention | No PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients who have a change in management resulting from PET
Measured: 12 months
Secondary outcomes (6)
proportion of patients precluded from having a liver resection because of additional metastatic disease identified on PET
Measured: 12 months
3-year overall survival of patients who undergo surgery with curative intent
Measured: 12 months
3-year overall survival of all patients
Measured: 12 months
sensitivity and specificity of PET in detecting other hepatic and extra-hepatic metastatic disease prior to a potentially curable liver resection for colorectal adenocarcinoma metastatic disease
Measured: 12 months
economic analysis of the addition of PET in the diagnostic work-up
Measured: 4 year
prognostic ability of the PET standard uptake value (SUV) in predicting 3-year overall survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionApr 2010
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- Steven Gallinger, MD, Study chair, University Health Network: Mount Sinai HospitalMark Levine, MD, Principal investigator, Ontario Clinical Oncology Group (OCOG)Carol-anne Moulton, MD, Principal investigator, University Health Network: Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265356
- Sponsor's protocol ID
- CTA-Control-098389
- Acronym
- PETCAM
- Status last verified
- Oct 2013
- First submitted
- 12 Dec 2005
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Serrano PE, Gafni A, Gu CS, Gulenchyn KY, Julian JA, Law C, Hendler AL, Moulton CA, Gallinger S, Levine MN. Positron Emission Tomography-Computed Tomography (PET-CT) Versus No PET-CT in the Management of Potentially Resectable Colorectal Cancer Liver Metastases: Cost Implications of a Randomized Controlled Trial. J Oncol Pract. 2016 Jul;12(7):e765-74. doi: 10.1200/JOP.2016.011676. Epub 2016 Jun 21.
PubMed 27328792Moulton CA, Gu CS, Law CH, Tandan VR, Hart R, Quan D, Fairfull Smith RJ, Jalink DW, Husien M, Serrano PE, Hendler AL, Haider MA, Ruo L, Gulenchyn KY, Finch T, Julian JA, Levine MN, Gallinger S. Effect of PET before liver resection on surgical management for colorectal adenocarcinoma metastases: a randomized clinical trial. JAMA. 2014 May 14;311(18):1863-9. doi: 10.1001/jama.2014.3740.
PubMed 24825641
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Positron Emission Tomography (PET) Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases: A Prospective, Multicentre Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00265356
- Acronym / sponsor ID
- PETCAM / CTA-Control-098389
- Conditions
- Colorectal Cancer, Liver Metastases
- Keywords
- Positron Emission Tomography (PET), Diagnostic Investigation, Colorectal cancer, Liver metastases, Liver surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Nov 2005
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 14 Dec 2005 (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.
The purpose of this trial is to improve the management of patients with potentially surgically curable colorectal cancer liver metastases.
The primary objective is to determine the impact of pre-operative positron emission tomography (PET) on patients who have been assessed as having resectable colorectal cancer liver metastases by conventional imaging (computed tomography (CT) abdomen/thorax, colonoscopy), by determining the proportion of patients who have a change in management resulting from PET.
Detailed description
Colorectal cancer remains a leading cause of death in men and women. A significant number of patients with colorectal cancer will either present with, or subsequently develop, liver metastases. In contrast to many other epithelial solid tumours, resection of colorectal cancer hepatic metastases results in long-term survival and even cure. However, despite state of the art CT imaging, 60-75% of patients who appear to have limited disease amenable to surgical resection will eventually die from extra-hepatic and recurrent hepatic metastases. If occult micrometastatic disease that becomes evident after liver resection could be detected reliably during pre-operative assessment, patients harboring more widespread disease could be spared a non-curative liver resection. This is one of the present challenges of liver surgery. PET imaging has the potential to improve the detection of both hepatic and extra-hepatic metastatic disease, not detected by conventional imaging modalities.
This prospective, multicenter trial will enroll patients with colorectal cancer liver metastases considered resectable, based on CT scans of the thorax, abdomen and pelvis, which demonstrate no evidence of extra-hepatic disease. A full colonoscopy within the preceding 12 months will ensure there is no local recurrence, or other primary cancer at the time of planned liver resection. These patients will be randomized to PET scan or not.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: PET diagnostic imagingPET diagnostic imaging |
| 2 | No intervention | –No PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologic proof of previous colorectal adenocarcinoma (not carcinoid, squamous cell cancer, gastrointestinal stromal tumor, or lymphoma)
- Contrast-enhanced spiral CT scan of the thorax, and a tri-phasic CT scan of the abdomen and pelvis performed within 30 days (plus up to 14 days) before randomization demonstrating resectable metastasis(es) that are isolated to the liver
- Full colonoscopy performed within the preceding 18 months showing no evidence of malignancy (other than a synchronous colorectal primary expected to be removed at time of liver resection)
- Age over 18 years
Key exclusion criteria (10 listed)
- Extrahepatic disease including enlarged portal lymph nodes on CT
- Prior liver resection
- Previous radiofrequency ablation of malignant liver lesion
- Systemic chemotherapy within three weeks prior to randomization
- Radiotherapy within two months prior to randomization
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 |
|---|---|---|
| PET diagnostic imagingAlso: Positron Emission TomographyPET diagnostic imaging | Procedure or surgery | 1 |
Primary outcome
proportion of patients who have a change in management resulting from PET
Time frame: 12 months
6 secondary outcomes
proportion of patients precluded from having a liver resection because of additional metastatic disease identified on PET
Time frame: 12 months
3-year overall survival of patients who undergo surgery with curative intent
Time frame: 12 months
3-year overall survival of all patients
Time frame: 12 months
sensitivity and specificity of PET in detecting other hepatic and extra-hepatic metastatic disease prior to a potentially curable liver resection for colorectal adenocarcinoma metastatic disease
Time frame: 12 months
economic analysis of the addition of PET in the diagnostic work-up
Time frame: 4 year
prognostic ability of the PET standard uptake value (SUV) in predicting 3-year overall survival
Time frame: 12 months
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 Oct 2013.
- Derived from this study: PubMed 27328792Serrano PE, Gafni A, Gu CS, Gulenchyn KY, Julian JA, Law C, Hendler AL, Moulton CA, Gallinger S, Levine MN. Positron Emission Tomography-Computed Tomography (PET-CT) Versus No PET-CT in the Management of Potentially Resectable Colorectal Cancer Liver Metastases: Cost Implications of a Randomized Controlled Trial. J Oncol Pract. 2016 Jul;12(7):e765-74. doi: 10.1200/JOP.2016.011676. Epub 2016 Jun 21.
- Derived from this study: PubMed 24825641Moulton CA, Gu CS, Law CH, Tandan VR, Hart R, Quan D, Fairfull Smith RJ, Jalink DW, Husien M, Serrano PE, Hendler AL, Haider MA, Ruo L, Gulenchyn KY, Finch T, Julian JA, Levine MN, Gallinger S. Effect of PET before liver resection on surgical management for colorectal adenocarcinoma metastases: a randomized clinical trial. JAMA. 2014 May 14;311(18):1863-9. doi: 10.1001/jama.2014.3740.
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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.
Steven Gallinger, MD study chair
University Health Network: Mount Sinai Hospital
Mark Levine, MD principal investigator
Ontario Clinical Oncology Group (OCOG)
Carol-anne Moulton, MD principal investigator
University Health Network: Toronto General Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PET diagnostic imaging in people with Colorectal Cancer and Liver Metastases, run by Ontario Clinical Oncology Group (OCOG) at 9 sites in Canada.
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 4 inclusion and 10 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 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
proportion of patients who have a change in management resulting from PET (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00265356, which also lists 2 linked publications.
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 Oct 2013.