- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04231175
Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer (DISCO)
Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer Patients; a Multicenter Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
CONTROL (ARM B) Standard work-up including computed tomography and surgical inspection as appropriate (based on a MDT decision).
MAIN STUDY PARAMETERS/ENDPOINTS
Primary outcome:
Number of preventable unnecessary laparoscopies and explorative laparotomies.
NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS:
MRI is a standard diagnostic procedure without the use of radiation. The MR sequences, MR-contrast agents and Buscopan (to minimize peristaltic bowel movements) are all commonly used in daily clinical practice. In addition, patients will be asked to drink 1L of pineapple juice 1-2 hours before the MRI (to minimize signal in the bowel lumen and optimize image quality), which is standard procedure in many clinics for MRCP and MR enterography. By acting upon the MRI findings in the experimental arm A, could result into new risks as oppose to standard clinical practice. However by introducing the borderline group ('yellow light' group) to receive diagnostic laparoscopy will minimize the possibility of over-staging a patient that would have received a successful CRS/HIPEC in de control arm. In our internal pilot data of 87 patients considered for CRS/HIPEC, no patients with a PCI of above 24 ended up receiving successful CRS/HIPEC and only 4 of the 15 patients that could have been assigned to the borderline group (were the trail to have run at that time) received successful CRS/HIPEC.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Max Lahaye, PhD MD
- Phone Number: +31 20 512 1012
- Email: m.lahaye@nki.nl
Study Contact Backup
- Name: Carine Sondermeijer, Bsc
- Phone Number: +31 20 512 7423
- Email: c.sondermeijer@nki.nl
Study Locations
-
-
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Amsterdam, Netherlands, 1066CX
- Recruiting
- Antoni van Leeuwenhoek
-
Contact:
- Carine Sondermeijer, Bsc
- Phone Number: +31 20 512 7423
- Email: c.sondermeijer@nki.nl
-
Contact:
- Max Lahaye, PhD, MD
- Phone Number: +31 20 512 1012
- Email: m.lahaye@nki.nl
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with suspicion of colorectal peritoneal metastases and considered for CRS/HIPEC
- Age ≥18 years
- Written and signed informed consent
- WHO 0-2
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental arm A
patients will undergo dedicated MRI imaging of the pelvis, abdomen, and thorax.
Based on the findings of the MRI scan patients will be allocated to one of the diagnostic/treatment options
|
Patients in Arm A will receive a MRI scan of their pelvis, abdomen, and thorax before possible surgery.
During the MRI standard Gadolinium contrast agent and Buscopan is intravenously administered, which is standard clinical practice in abdominal MR imaging.
Total scan time is 35 minutes and includes T2 weighted, T1 weighted, Diffusion weighted and dynamic contrast enhanced imaging of the abdomen and the thorax.
The findings of this scan will be used to determine whether to proceed with CRS/HIPEC, DLS and then possibly CRS-HIPEC, or palliative care.
|
No Intervention: arm B
patients will undergo the current standard diagnostic work-up of DLS at indication (MDT decision) and otherwise continue to CRS-HIPEC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
4 weeks
|
Number of preventable unnecessary laparoscopies and explorative laparotomies defined as
Time Frame: 4 weeks
|
(II) incomplete CRS-HIPEC (R2A/R2B/open-close procedures)
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4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
- Number of additional extra-peritoneal findings
Time Frame: 4 weeks
|
Number of additional extra-peritoneal findings
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4 weeks
|
- Number of early recurrences (with-in 6 months after R1 resection and HIPEC)
Time Frame: 6 months
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- Number of early recurrences (with-in 6 months after R1 resection and HIPEC)
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6 months
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- Diagnostic performance of Peritoneal Cancer Index determined by MRI (MRI-PCI) to predict surgical Peritoneal Cancer Index (S-PCI).
Time Frame: 6 months
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- The Peritoneal Cancer Index (PCI) system reported by Sugerbaker [24] will be determined by indicating the presence of large (>5cm), moderate (<5cm - >0.5cm), small (<0.5cm) or no involvement in 13 abdominal regions
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6 months
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- Inter-observer agreement between different readers for DW-MRI.
Time Frame: 6 months
|
Readers will evaluate the following MR criteria that might result in an incomplete CRS with a confidence level score (0 to 5):
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6 months
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Incremental cost-effectiveness ratio
Time Frame: 6 months
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The direct costs will include costs of standard treatment (chemotherapy and cytoreductive surgery), costs of diagnostic work-up (standard and MRI) and treatment of adverse events/surgical complications, follow-up visits, recurrences and palliative care (measured as possible within the trial period).
From this the cost effectiveness will be determined.
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6 months
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Quality of Life between diagnostic arms by EORTC-C30 -
Time Frame: 6 months
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The following questionnaire will be used to measure HRQoL in patients EORTC-C30.
This will be completed at baseline, 3 & 6 months following randomisation.
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6 months
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Quality of Life between diagnostic arms by EQ5D5L
Time Frame: 6 months
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The following questionnaire will be used to measure HRQoL in patients EQ5D5L.
This will be completed at baseline, 3 & 6 months following
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Max Lahaye, PhD MD, Antoni van Leeuwenhoek
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Abdominal Neoplasms
- Carcinoma
- Colorectal Neoplasms
- Peritoneal Neoplasms
Other Study ID Numbers
- M19DSC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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