LOTCOL Study: Local Treatment of Colo-rectal Liver Met (LOTCOL)

January 6, 2017 updated by: Svein Dueland, Oslo University Hospital

A Randomized Study With Palliative Chemotherapy With or Without Local Treatment of Liver Metastases in Patients With Colo-rectal Cancer

In this study the investigators will include colo-rectal cancer (CRC) patients starting last line of standard palliative chemotherapy. Eligible patients include patients with KRAS mutation starting line or KRAS wild type starting line treatment. Standard treatment today for these patients is chemotherapy only and median overall survival (OS) is about 10 months. The hypothesis is that local treatment in addition to systemic treatment will increase time to progression, progression free survival and overall survival compared to patients who receive systemic chemotherapy only. The investigators experience with local treatment of liver metastases in CRC patients is that side-effects of treatment in general are minor, although gastric bleeding have been observed after stereotactic body radiation therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, N-0310
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically verified adenocarcinoma of colon or rectum
  • Ambulatory with an ECOG performance status 0-2
  • At least 18 years of age
  • Non-resectable liver metastases
  • Progressive disease on or within 4 months after 1.line chemotherapy for KRAS mutant or after 2.line chemotherapy in KRAS wild type patients
  • 1-4 liver metastases with largest diameter of up to 6 cm on CT-scan
  • Up to 20 lesions in liver with no more than 4 lesions larger than 4 cm
  • The patients will start 2./3. line chemotherapy (KRAS mutant/KRAS wt)

  • Laboratory values as the following:

    • ANC ³ 1.5 x 109/L
    • Platelets ³ 100 x 109/L
    • Hb ³ 9g/dL
    • Creatinine £ 2x upper limit of normal
    • Bilirubin < 2.0x the upper limit of normal
    • ASAT and ALAT £ 5x the upper limit of normal
    • Albumin levels > 30 g/L
    • INR<1.3
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations

Exclusion Criteria:

  • Previous treatment with 2. or 3. line chemotherapy (KRAS mutant/KRAS wt)
  • History of prior metastatic disease the last 3 years
  • History of CNS or bone metastases
  • Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
  • Largest liver mets >6 cm, more than 4 liver lesions >4 cm
  • Pulmonary mets>3 cm
  • Lymph node mets >2.5 cm
  • Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
  • Any reason why, in the opinion of the investigator, the patient should not participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cheomotherapy and local treatment
Standard chemotherapy + local treatment
Procedure: Radiofrequency ablation, microwave, radiation therapy
Radiofrequency ablation Microwave ablation Radiation therapy
Placebo Comparator: Cheomotherapy
Standard chemotherapy
Drug: Standard Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival from time of randomization
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1392 REK South East C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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