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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024890
Receipt No. R000027588
Scientific Title Diffusion-Weighted Magnetic REsonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning (EORTC-1527-GITCG-IG/ JCOG1609INT, DREAM)
Date of disclosure of the study information 2016/11/18
Last modified on 2016/11/18

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Basic information
Public title Diffusion-Weighted Magnetic REsonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning (EORTC-1527-GITCG-IG/ JCOG1609INT, DREAM)
Acronym Diffusion-Weighted Magnetic REsonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning (EORTC-1527-GITCG-IG/ JCOG1609INT, DREAM)
Scientific Title Diffusion-Weighted Magnetic REsonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning (EORTC-1527-GITCG-IG/ JCOG1609INT, DREAM)
Scientific Title:Acronym Diffusion-Weighted Magnetic REsonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning (EORTC-1527-GITCG-IG/ JCOG1609INT, DREAM)
Region
Japan Europe

Condition
Condition colorectal liver metastases
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the diagnostic performance of multi-parametric MRI to predict the nature of confirmed disappearing liver metastases (cDLMs) that were either resected or left behind after surgery using histopathology and imaging within two years of the initial surgery, respectively, as the best available reference of true lesion status
* In this study, "cDLMs" are defined as lesions not detected on both pre-operative CT scan and multiparametric MRI [DW-MRI, T1/T2 and CE-MRI (either hepatocyte specific and or extracellular)]
Basic objectives2 Others
Basic objectives -Others Negative predictive value of CT and MRI
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 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)
Key secondary outcomes 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)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion 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.
Key exclusion criteria none
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Serge Evrard
Organization Institut Bergonie
Division name Digestive Tumors Unit
Zip code
Address 229 Cours de l'Argonne, 33000,Bordeaux, France
TEL +33-556-333-266
Email s.evrard@bordeaux.unicancer.fr

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Shiozawa
Organization JCOG1609INT Coordinating Office
Division name Kanagawa Cancer Center
Zip code
Address 2-3-2 Nakao, Asahi-ku Yokohama, Kanagawa 241-8515
TEL +81-45-520-2222
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute European Organisation for Research and Treatment of Cancer (EORTC)
Institute
Department

Funding Source
Organization EORTC
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Belgium

Other related organizations
Co-sponsor Japan Clinical Oncology Group (JCOG)
Name of secondary funder(s) Japan Agency for Medical Research and Development

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 ClinicalTrials.gov by NLM (NCT02781935)
Org. issuing International ID_1 ClinicalTrials.gov by NLM (NCT02781935)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 山形県立がんセンター(山形県)
群馬県立がんセンター(群馬県)
自治医科大学附属さいたま医療センター(埼玉県)
千葉県立がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
東京医科歯科大学(東京都)
神奈川県立がんセンター(神奈川県)
新潟県立がんセンター(新潟県)
岐阜大学病院(岐阜県)
静岡県立がんセンター(静岡県)
大阪府立病院機構大阪府立成人病センター(大阪府)
広島県立病院(広島県)

Visceral, Transplantation and Thoracic Surgery Department(Austria)
KH Rudolfstiftung(Austria)
Medical University of Vienna(Austria)
Bergonie(France)
Gustave Roussy(France)
Centre Leon Berard(France)
Ospedale di Cittadella(Italy)
University of Siena(Italy)
M Sklodowska Curie Memorial Cancer Center(Poland)
Medical University of Lublin(Poland)
Military Medical Academy(Serbia)
University of Novi Sad - Faculty of Medicine(Serbia)
ROYAL MARSDEN NHS FOUNDATION TRUST(UK)
University hospital Aintree NHS Trust(UK)
Belgium University Hospitals Leuven(Belgium UZ Ghent)
Oregon Health and Science University/Knight Cancer Institute(USA)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 18 Day
Last follow-up date
2021 Year 11 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is an Intergroup Study, jointly conducted within the network of the EORTC, ESSO and JCOG in different countries of the European and Japan.
The EORTC is the leading group in this study and therefore centrally manages study design and activation, attribution of duties and responsibilities between participating research groups, data collection and quality control of data, statistical analysis and publication.
The JCOG will manage the patient accrual from Japanese institutions as the cooperating group. The sponsor of JCOG is National Cancer Center.

Management information
Registered date
2016 Year 11 Month 18 Day
Last modified on
2016 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027588

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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