Clinical trial NCT01867918: LOTCOL Study: Local Treatment of Colo-rectal Liver Met
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
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Colo-rectal Cancer
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall survival from time of randomization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: