UMIN-CTR Clinical Trial

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

colorectal liver metastases

Classification by specialty

Gastrointestinal surgery

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

European Organisation for Research and Treatment of Cancer (EORTC)

Institute

Department

Personal name

Organization

EORTC

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Belgium

Co-sponsor

Japan Clinical Oncology Group (JCOG)

Name of secondary funder(s)

Japan Agency for Medical Research and Development

Organization

Address

Tel

Email

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

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)

Date of disclosure of the study information

2016

Year

11

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2016

Year

11

Month

18

Day

Last modified on

2016

Year

11

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027588