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The International Liver Tumor Group RAS-trial Radiofrequency Ablation Versus Stereotactic Body Radiation Therapy for Colorectal Liver Metastases: A Randomized Trial


Phase 3
18 Years
90 Years
Open (Enrolling)
Both
Colorectal Carcinoma, Liver Metastases

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Trial Information

The International Liver Tumor Group RAS-trial Radiofrequency Ablation Versus Stereotactic Body Radiation Therapy for Colorectal Liver Metastases: A Randomized Trial


Patients with 1-4 inoperable colorectal liver metastases, no more 4 cm in diameter are
randomized to either RFA or SBRT. Primary end point i local progression free survival.
Chemotherapy is allowed before and after study treatment.


Inclusion Criteria:



- Adenocarcinoma of the colon or rectum

- Liver metastases

- Inoperable (technical or medical)

- 1-4 metastases

- Maximum 40 mm in diameter

- Suitable for both therapies, RFA and SBRT

Exclusion Criteria:

- Uncontrolled extrahepatic disease and uncontrolled primary cancer

- Liver cirrhosis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Local progression-free survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Morten Høyer, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aarhus University Hospital

Authority:

Sweden: Regional Ethical Review Board

Study ID:

RAS 01

NCT ID:

NCT01233544

Start Date:

September 2010

Completion Date:

December 2016

Related Keywords:

  • Colorectal Carcinoma
  • Liver Metastases
  • Colorectal carcinoma
  • Liver metastases
  • Stereotactic body radiation therapy
  • Radiofrequency ablation
  • Carcinoma
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

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