Therasphere treatment of liver metastases from colorectal cancer
Research type
Research Study
Full title
A Phase III Clinical Trial Evaluating TheraSphere® in Patients with Metastatic Colorectal Carcinoma of the Liver who have Failed First Line Chemotherapy
IRAS ID
135118
Contact name
Ewan Brown
Contact email
Sponsor organisation
Biocompatibles UK Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-11-12-003422, Eudamed number for EU
Duration of Study in the UK
3 years, 1 months, 1 days
Research summary
Research Summary
Metastatic colorectal cancer is cancer in the liver that has spread from the colon or rectum. TheraSphere is a medical device that is approved in Europe (CE marked) for the treatment of liver cancer. It consists of millions of microscopic glass spheres that are injected into the main arteries of the liver to deliver radiation therapy directly to the tumor.
Colorectal cancer is treated with combinations of chemotherapy agents, most frequently including drugs called oxaliplatin or irinotecan. Patients who have completed their first series of chemotherapy treatment and whose doctor is planning to use a second combination of drugs to continue their cancer treatment may be suitable for this study. This is called second-line chemotherapy.
The purpose of this research study is to examine whether adding treatment with TheraSphere early in the current standard for second-line chemotherapy treatment of metastatic colorectal cancer is better than the current treatment alone.
There will be two treatment groups. All patients will receive their planned standard-of-care second-line chemotherapy. They have an equal chance (like flipping a coin) of receiving no added study therapy or TheraSphere treatment in place of one chemotherapy treatment. The doses, duration of treatment and schedule of therapies that participants will receive will depend on the group to which they are assigned.
About 340 patients will be enrolled in this study at approximately 100 hospitals in the United States, Canada, Europe and Asia.Summary of Results
The study showed that the addition Y-90 radioembolization / Therasphere (TS) to second-line chemotherapy improved overall and hepatic progression-free survival for patients with colorectal liver metastases. Specifically, patients receiving TheraSphere treatment with second-line chemotherapy were 31% less likely to show disease progression or death and 41% less likely to show hepatic disease progression or death versus with chemotherapy alone. This is the first study to investigate the role of transarterial radioembolization with Y-90 when added to standard of care second line chemotherapy for patients with colorectal liver metastases.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
14/SC/1366
Date of REC Opinion
1 Dec 2014
REC opinion
Favourable Opinion