LOTCOL Study: Local Treatment of Colo-rectal Liver Met

University of Oslo (UIO)

Status: Terminated

Conditions: Metastatic Colo-rectal Cancer

Treatments: Procedure: Radiofrequency ablation, microwave, radiation therapy; Drug: Standard Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01867918

2012/1392 REK South East C

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 2 patient groups, including a placebo group

Cheomotherapy and local treatment

Experimental group

Description:

Standard chemotherapy + local treatment

Treatment:

Procedure: Radiofrequency ablation, microwave, radiation therapy

Cheomotherapy

Placebo Comparator group

Description:

Standard chemotherapy

Treatment:

Drug: Standard Chemotherapy