Diffusion-Weighted Magnetic REsonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning (EORTC-1527-GITCG-IG/ JCOG1609INT, DREAM)

UMIN ID: UMIN000024890

Registered date:18/11/2016

Basic Information

• Recruitment status: Open public recruiting
• Health condition(s) or Problem(s) studied: colorectal liver metastases
• Date of first enrollment: 2016/11/18
• Target sample size: 400
• Countries of recruitment: Japan,Europe
• Study type: Interventional
• Intervention(s): A: Among unresectable/borderline colorectal liver metastases patients who become resectable after chemotherpy, information of DLM/cDLM is collected and analyzed. Imaging modalitiy, surgery and chemotherapy used in this study are standard of care. Only interventional part is that CT and MRIs (DW-MRI, T1/T2. contranst enhanced MRI) are required two years after surgery when no recurrence was observed at the site of DLM/cDLM

Outcome(s)

• Primary Outcome: Negative predictive value (NPV) of DW-MRI, T1/T2, CE-MRI and standard CT scan combined for the detection of non viable lesions after conversion therapy among those with confirmed DLMs that were either resected (using histopathology) or left behind (using imaging findings of absence of recurrence of the lesions within two years)

Secondary Outcome

Key secondary endpoints:
･ NPV of DW-MRI, T1/T2, CE-MRI and standard CT scan combined for the detection of non viable lesions after conversion chemotherapy in the group of resected cDLMs
･NPV of DW-MRI, T1/T2, CE-MRI and standard CT scan combined in the group of cDLMs that were left in place
Secondary endpoints
･ Frequency of disappearing lesions by patient for each imaging modality (CT scan, DW-MRI, Gd-EOB MRI, intraoperative ultrasound)
･ NPV of DW-MRI in the group of cDLMs diagnosed by central imaging review that were resected and that are left behind
･ Complete (TRG1) and major (TRG1+TRG2) pathologic response rate of small lesions (scar and calcifications)
･ Recurrence rate of cDLMs which were ablated
･ The correlation between different types of radiologic (morphologic and ADC) changes and TRG to the type of conversion therapy
･ The correlation between morphologic change of liver after chemotherapy and postoperative complication rate
･ NPV of other each imaging modality (CT, DW-MRI and CE-MRI (hepatocyte-specific/extracellular))
･ Postoperative complication rate at 30 and 90 days
･ Local recurrence rate (post-surgery)
･ PFS (post-surgery)
･ OS (post-surgery)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female

Include criteria

Criteria for registration
･ Age >=18 years old
･ Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
Criteria for Eligibility
･ Primary tumor histologically proven as colorectal adenocarcinoma
･ Unresectable or borderline resectable liver metastases at the time of diagnosis for liver metastases.
･ Presence of extrahepatic distant metastases is allowed as long as these lesions are considered as resectable
･ Contrast-enhanced thorax, abdomen and pelvic CT scanat diagnosis is available
･ Multiparametric MRI is available.
･ No contraindications to any contrast agents for CT and MRI or MRI procedure
･ WHO performance status of 0 or 1
･ Previous treatments for primary, liver and extra-hepatic metastases are allowed.
･ No significant comorbidity that will preclude either conversion therapy or surgery
･ No other malignancies in the 3 years prior to study entry
･ Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
･ Pregnancy is a contraindication in this study.
Criteria for Enrollment
･ At least 2 cycles of chemotherapy have been given as a part of conversion therapy. Any regimen and schedule of chemotherapy are allowed.
･ At least 2 sets (at liver metastasis diagnosis and preoperative) of contrast-enhanced CT scan are available
･ At least 2 sets of multiparametric MRI (baseline and preoperative) are available
･ Interval between the two MRIs should be at least 4 weeks.
･ Patient is suitable for hepatic resection based on the assessment of MDT prior to any liver surgery. MDT is composed of at least an expert liver/colorectal surgeon, Gastrointestinal (GI) radiologist and oncologist prior to any liver surgery. Attendance of pathologist is recommended
･ Hepatic resection is scheduled within 8 weeks of latest imaging.

• Exclude criteria: none

Related Information

• Primary Sponsor: European Organisation for Research and Treatment of Cancer (EORTC)
• Secondary Sponsor: Japan Clinical Oncology Group (JCOG)
• Source(s) of Monetary Support: EORTC
• Secondary ID(s): ClinicalTrials.gov by NLM (NCT02781935)