NCT00152906

Stereotactic Radiotherapy (SRT) Liver (COLD 1)

Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A minority of patients with colorectal liver metastases and hepatobiliary cancer (primary liver cancer) are candidates for surgery, but there are no curative treatment options for these patients. Their median survival time is 3 to 12 months. Stereotactic radiation (SRT) (highly conformal radiotherapy (CRT)) is a treatment option for these patients with unresectable liver cancer, now possible due to improvements in our ability to localize and immobilize liver tumors and an improved understanding of the partial liver volume tolerance to radiation. SRT should permit liver tumors to be treated to tumorcidal doses while sparing the uninvolved liver, decreasing the risk of treatment related normal tissue toxicity. With such conformal radiation, it is possible to deliver radiation in fewer fractions than traditionally required, which should be more convenient for patients. In this study, CRT will be delivered during shallow breathing or breath hold to minimize organ motion due to breathing, decreasing the volume of normal liver that must be irradiated.

Conditions

• Liver Neoplasms
• Neoplasm Metastases

Interventions

Type	Name	Description
PROCEDURE	Stereotactic radiotherapy (SRT) or highly conformal (CRT)	SRT or CRT is radiation delivered precisely conforming the high dose region to the tumor, usually in a few highdose fractions.

Timeline

• Start date: 2003-07-01
• Primary completion: 2016-07-01
• Completion: 2020-07-10
• First posted: 2005-09-09
• Last updated: 2020-08-14

Locations

1 site across 1 country: Canada