Impact of Positron Emission Tomography Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases

NCT ID: NCT00265356

Last Updated: 2013-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2013-04-30

Brief 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 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.

Conditions

Colorectal Cancer; Liver Metastases

Keywords

Positron Emission Tomography (PET); Diagnostic Investigation; Colorectal cancer; Liver metastases; Liver surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

PET diagnostic imaging

Group Type: EXPERIMENTAL

PET diagnostic imaging

Intervention Type: PROCEDURE

PET diagnostic imaging

2

No PET

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PET diagnostic imaging

PET diagnostic imaging

Intervention Type: PROCEDURE

Other Intervention Names

Positron Emission Tomography

Eligibility Criteria

Inclusion Criteria

1. Histologic proof of previous colorectal adenocarcinoma (not carcinoid, squamous cell cancer, gastrointestinal stromal tumor, or lymphoma)

2. 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

3. 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)

4. Age over 18 years

Exclusion Criteria

1. Extrahepatic disease including enlarged portal lymph nodes on CT

2. Prior liver resection

3. Previous radiofrequency ablation of malignant liver lesion

4. Systemic chemotherapy within three weeks prior to randomization

5. Radiotherapy within two months prior to randomization

6. Significant concurrent medical problems (e.g., uncontrolled diabetes, active cardiac disease, significant chronic obstructive pulmonary disease) making the patient unfit for surgery

7. Pregnant or lactating female

8. Unable to lie supine for imaging with PET

9. Previously treated cancer other than non-melanocytic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater

10. Patients who, at the time of the initial evaluation, have already undergone a whole body PET within 6 months prior to randomization

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Gallinger, MD

Role: STUDY_CHAIR

University Health Network: Mount Sinai Hospital

Mark Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Ontario Clinical Oncology Group (OCOG)

Carol-anne Moulton, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network: Toronto General Hospital

Locations

Hamilton Health Sciences

Hamilton, Ontario, Canada

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

Grand River Regional Cancer Centre

Kitchener, Ontario, Canada

London Health Sciences

London, Ontario, Canada

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

St. Joseph's Health Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 27328792 (View on PubMed)

Moulton 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.

Reference Type: DERIVED

PMID: 24825641 (View on PubMed)

Other Identifiers

CTA-Control-098389

Identifier Type: -

Identifier Source: org_study_id