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Liver MetastasesNCT02355353

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

A study testing Experimental: imaging arm in people with Liver Metastases and Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Metastases, Colorectal Cancer
What is being tested?
Experimental: imaging arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
No sites listed yet
Study dates
Feb 2015to Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Previous adjuvant chemotherapy for primary CRC is allowed if completed at least 12 months before inclusion in this study.
  • All the following tests should be done within 6 weeks prior to registration:
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  • 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.
  • Before patient registration, written informed consent must be given according to International Conference on Harmonization of Good Clinical Practice (ICH/GCP), and national/local regulations.

Who cannot join

  • 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
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  • 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.
  • Treatment with Cytochrome P450 3A4 (CYP3A4) inducers, unless discontinued > 7 days prior to step 2 of registration.

Trial locations and contacts

No sites are listed yet.

Oussama Karroum contact

003227741523

oussama.karroum@eortc.be

About this study

Official title: Evaluation of Diffusion Weighted Imaging -MRI in Patients With Resectable Liver Metastases From Colorectal Cancer Treated With Fluoropyrimidine-based Chemotherapy as Preoperative Treatment

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.

Read the detailed description

This is a prospective, multicenter, single-arm imaging trial. Patients with resectable liver metastases from colorectal cancer (CRC) will undergo Diffusion Weighted Imaging- Magnetic Resonance Imaging (DWI-MRI) scans at least at three separate occasions: at baseline, at 14 days (maximum +/- 1 days deviation is acceptable) after first administration of chemotherapy and finally after up to 6 cycles of chemotherapy (one week prior to surgery).

All patients registered in the study may participate to the test-retest analysis. This analysis required a double baseline scans (called test-retest) to be done on two separate occasions, separated from each other by from one hour to one week but both before start of therapy. The repeated scan at baseline (retest) is optional as it will be used only for the test-retest repeatability analysis.

Dedicated in-house developed software will be used to quantify ADC to assess tumor characteristics and response to therapy.

Being tested
Experimental: imaging arm
Keywords
DWI-MRI, resectable liver metastases
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: imaging armOther

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

Study groups in NCT02355353
Study groupRoleWhat they receive
Imaging armExperimentalNot described
Receives: Other: Experimental: imaging arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of ADC changes

    Percentage of ADC changes at day 14 relative to baseline

    Measured: at day 14 relative to baseline

  2. Tumor regression grade (TRG)

    Tumor regression grade (TRG) in the surgical resection specimen

    Measured: After surgery, up to 22 weeks from baseline

Secondary outcomes (4)

  1. Repeatability Coefficient

    Repeatability Coefficient from test-retest ADC measurements at baseline

    Measured: from test-retest ADC measurements at baseline

  2. Pre-operative (post-treatment) ADC measurement

    Pre-operative (post-treatment) ADC measurement

    Measured: up to 21 weeks after baseline

  3. Lesion volume

    Lesion volume (baseline and, if applicable, after 3 cycles and after 6 cycles) using radiological assessment

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

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

    Histopathological measurements on liver metastases Tumor tissue cellularity/density, Necrosis, Proliferation (ki-67)

    Measured: At baseline and up to 22 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionSep 2016 (estimated)
  4. Study completionFeb 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02355353
Sponsor's protocol ID
EORTC-1423
Status last verified
Jan 2015
First submitted
27 Jan 2015
Last updated
4 Feb 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: imaging arm in people with Liver Metastases and Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Oussama Karroum (003227741523, oussama.karroum@eortc.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of ADC changes (time frame: at day 14 relative to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02355353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.

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