Evaluation of Diffusion Weighted Imaging -MRI in Patients With Resectable Liver Metastases From Colorectal Cancer

NCT02355353 | Unknown DMC

• 1 other identifier: EORTC-1423
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to correlate the percentage change in apparent diffusion coefficient (ADC) between baseline and early therapy (at day 14) with tumor regression grade (TRG) measured in the surgical resection specimen.

Conditions

Liver Metastases; Colorectal Cancer

Keywords

DWI-MRI; resectable liver metastases

Outcome Measures

Primary Outcomes (2)

• Percentage of ADC changes

  Percentage of ADC changes at day 14 relative to baseline

  at day 14 relative to baseline

• Tumor regression grade (TRG)

  Tumor regression grade (TRG) in the surgical resection specimen

  After surgery, up to 22 weeks from baseline

Secondary Outcomes (4)

• Repeatability Coefficient

  from test-retest ADC measurements at baseline

• Pre-operative (post-treatment) ADC measurement

  up to 21 weeks after baseline

• Lesion volume

  AT baseline, after 9 weeks and after 18 weeks of chemotherapy

• Histopathological measurements of tumor tissue cellularity /density, Necrosis, Proliferation (ki-67)

  At baseline and up to 22 weeks after baseline

Study Arms (1)

Imaging arm

EXPERIMENTAL

Other: Experimental: imaging arm

Interventions

Experimental: imaging arm OTHER

DWI-MRI scans at baseline, at 14 days after first administration of chemotherapy and after up to 6 cycles of chemotherapy

Imaging arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven CRC with metachronous or synchronous liver metastases considered to be completely upfront resectable.
• Patients with at least one measurable liver lesion (\> 2 cm), measured by contrast CT or MRI at baseline. At least one liver metastasis should be clearly identified and provide a high likelihood of successful resection in the later surgery.
• Patients must be 18 years old or older.
• A World Health Organization (WHO) performance status of 0 or 1.
• All the following tests should be done within 6 weeks prior to registration:
• Hematological status: neutrophils (ANC) ≥ 1.5x109/L; platelets ≥ 100x109/L; haemoglobin ≥ 9g/dL.
• Serum creatinine ≤ 1.5 times the upper limit of normal (ULN).
• No significant proteinuria (\< 2+ proteinuria on urine dipstick or urine protein \< 1g/24 hours urine collection).
• Liver function: serum bilirubin ≤ 1.5 x ULN, alkaline phosphatase, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤ 5x ULN.
• No hypercalcemia: ionized calcium ≤1.5 mmol/L.
• Patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry are acceptable. This will not apply for Renal Function, including Creatinine.
• Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 14 days before trial registration.
• Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
• Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

You may not qualify if:

• Evidence of extra-hepatic metastasis (of CRC).
• Previous chemotherapy for metastatic disease or surgical treatment (e.g. surgical resection or radiofrequency ablation) for liver metastasis. Previous radiotherapy or embolization treatment on liver is not allowed.
• Major surgical procedure, open biopsy, or significant traumatic injury in liver within 4 weeks prior to registration.
• Other malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.
• Prior (less than 12 months prior to start treatment) or planned concurrent use of anti-angiogenic drugs such as bevacizumab in the back-bone chemotherapy
• Prior (less than 12 months prior to start treatment) or planned concurrent use of anti-Epidermal Growth Factor Receptor (EGFR) monoclonal Antibody (mAb) such as panitumumab or cetuximab in the back-bone chemotherapy
• Regular use of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Ongoing bleeding diathesis (e.g. hemoptysis of ≥ 1/2 teaspoon or 2.5 mL), coagulopathy, or need for administration of full-dose anti-coagulant(s).
• Known history of myocardial infarction and/or stroke within 6 months prior to registration and /or New York Heart Association (NYHA) class III and IV congestive heart failure.
• Uncontrolled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy.
• History or evidence upon physical examination of Central Nervous System (CNS) metastasis.
• Bowel obstruction.
• Known allergy to any excipient of the standard chemotherapy agents
• Known intolerance to atropine or loperamide.
• Gilbert syndrome.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sigrid Stroobants

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oussama Karroum

CONTACT

003227741523; oussama.karroum@eortc.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 4, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: February 1, 2017
• Last Updated: February 4, 2015

Record last verified: 2015-01