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


N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colo-rectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival from time of randomization

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

Norway: The Regional Comittees for Medical and Health Research Ethics

Study ID:

2012/1392 REK South East C

NCT ID:

NCT01867918

Start Date:

May 2013

Completion Date:

December 2017

Related Keywords:

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

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