Status:
TERMINATED
LOTCOL Study: Local Treatment of Colo-rectal Liver Met
Lead Sponsor:
Oslo University Hospital
Conditions:
Metastatic Colo-rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 li...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01867918
Start Date
May 1 2013
End Date
December 1 2016
Last Update
January 9 2017
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, N-0310