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

Primary Purpose

Metastatic Colo-rectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Radiofrequency ablation, microwave, radiation therapy
Standard Chemotherapy
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colo-rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cheomotherapy and local treatment

Cheomotherapy

Arm Description

Standard chemotherapy + local treatment

Standard chemotherapy

Outcomes

Primary Outcome Measures

Overall survival from time of randomization

Secondary Outcome Measures

Full Information

First Posted
May 3, 2013
Last Updated
January 6, 2017
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01867918
Brief Title
LOTCOL Study: Local Treatment of Colo-rectal Liver Met
Acronym
LOTCOL
Official Title
A Randomized Study With Palliative Chemotherapy With or Without Local Treatment of Liver Metastases in Patients With Colo-rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Insuffisient recruitment
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colo-rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cheomotherapy and local treatment
Arm Type
Experimental
Arm Description
Standard chemotherapy + local treatment
Arm Title
Cheomotherapy
Arm Type
Placebo Comparator
Arm Description
Standard chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation, microwave, radiation therapy
Intervention Description
Radiofrequency ablation Microwave ablation Radiation therapy
Intervention Type
Drug
Intervention Name(s)
Standard Chemotherapy
Primary Outcome Measure Information:
Title
Overall survival from time of randomization
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

LOTCOL Study: Local Treatment of Colo-rectal Liver Met

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