LOTCOL Study: Local Treatment of Colo-rectal Liver Met

Metastatic Colo-rectal Cancer Clinical Trial

— LOTCOL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01867918
• Other study ID #: 2012/1392 REK South East C
• Secondary ID: 2012/1392 REK So
• Status: Terminated
• Phase: N/A
• First received: May 3, 2013
• Last updated: January 6, 2017
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: The Regional Comittees for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colo-rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Radiofrequency ablation, microwave, radiation therapy
Radiofrequency ablation Microwave ablation Radiation therapy

Drug:
• Standard Chemotherapy

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival from time of randomization		6 months	No