Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer Patients; a Multicenter Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 272
- Locations
- 2
- Primary Endpoint
- Number of preventable unnecessary laparoscopies and explorative laparotomies defined as:
Study Overview
Brief Summary
MRI is a potentially powerful tool to reliably determine the intra-abdominal tumor load and relations with intra-abdominal organs. In recent years diffusion weighted MRI has proven its value as a highly sensitive technique to detect small malignant disease in a wide variety of cancers [1-3]. However, literature concerning the clinical impact of detecting peritoneal metastases with MRI is very limited. Therefore, there is a need for a large randomized multicenter trial to determine whether dedicated MRI can be used as a selection tool for CRS-HIPEC candidates in daily practice.
Detailed Description
HYPOTHESIS Staging with dedicated MRI will lead to a reduction of staging laparoscopies and explorative laparotomies in colorectal patients with PM to evaluate whether they may benefit from CRS-HIPEC
OBJECTIVES The goal is to perform a multicenter randomized study to compare a less invasive diagnostic workup ARM A (with MRI and surgical inspection reserved for borderline operable cases on MRI) to the standard diagnostic workup (ARM B, without MRI, with surgical staging to determine resectability based on a MDT decision) of patients with (suspected) peritoneal metastases. Surgical staging laparoscopies may largely be replaced by MRI (only reserved as a problem solver for borderline operable cases in ARM A). If it will be proven that MRI is an accurate, robust and cost-effective staging tool than this will result in a more patient friendly diagnostic workup with less futile surgical procedures.
STUDY DESIGN 4-year multicenter randomized controlled trial
STUDY POPULATION N=272 patients suspected of synchronous or metachronous peritoneal metastases of colorectal origin who are considered for CRS-HIPEC after CT imaging.
EXPERIMENTAL (ARM A) CRS-HIPEC candidates are selected based on MRI and only in borderline cases a surgical inspection will be performed
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with suspicion of colorectal peritoneal metastases and considered for CRS/HIPEC
- •Age ≥18 years
- •Written and signed informed consent
- •Able and willing to drink 1 liter of pineapple or blueberry juice
Exclusion Criteria
- •- Patients with contraindications for the MRI:
- •Patients who have a heart pacemaker may not have an MRI scan
- •Patients who have a metallic foreign body (metal sliver) in their body
- •Patients with severe claustrophobia
- •Ineligible to receive gadofosveset (Gadolinium) contrast (history of contrast allergy, impaired kidney function with a Glomerular Filtration Rate <30 ml/min/1.73m2)
- •Ineligible to receive Buscopan
- •Allergy for pineapple juice and blueberry juice.
- •Patients with clinical contraindications for CRS/HIPEC
- •Patients with radiological contra-indications for CRS/HIPEC observed on CT thorax/abdomen
- •Massive mesenteric or small bowel involvement which would lead to short bowel syndrome if adequately resected
- •Extra-peritoneal metastases for which CRS/HIPEC is not justifiable (such as lung metastases, skeletal metastases, and liver metastases)
- •Inoperable retroperitoneal lymphadenopathy
- •Patients with a known additional malignancy, unless o treated with curative intent at least five years ago. in situ cancers, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that have undergone potentially curative therapy within the past five years
Outcomes
Primary Outcomes
Number of preventable unnecessary laparoscopies and explorative laparotomies defined as:
Time Frame: 4 weeks
(I) patients with a PCI\<15 at laparoscopy or PCI\>24 at laparotomy (II) incomplete CRS-HIPEC (R2A/R2B/open-close procedures)
Number of preventable unnecessary laparoscopies and explorative laparotomies defined as
Time Frame: 4 weeks
(II) incomplete CRS-HIPEC (R2A/R2B/open-close procedures)
Secondary Outcomes
- - Number of early recurrences (with-in 6 months after R1 resection and HIPEC)(6 months)
- - Diagnostic performance of Peritoneal Cancer Index determined by MRI (MRI-PCI) to predict surgical Peritoneal Cancer Index (S-PCI).(6 months)
- - Number of additional extra-peritoneal findings(4 weeks)
- - Inter-observer agreement between different readers for DW-MRI.(6 months)
- Quality of Life between diagnostic arms by EORTC-C30 -(6 months)
- Incremental cost-effectiveness ratio(6 months)
- Quality of Life between diagnostic arms by EQ5D5L(6 months)