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About this trial

Chemotherapy is a common treatment for bowel cancer that has spread to other parts of the body. S 95005 is a chemotherapy drug, known as trifluridine/tipiracil or by its brand name Lonsurf. S 95005 on its own is already a possible treatment for metastatic bowel cancer.
Doctors think that S 95005 can stop bowel cancer cells from making and repairing DNA. Cancer cells need to make and repair DNA so that they can grow and multiply.

Everyone taking part in this trial has 1 of the following:
• S 95005 with bevacizumab (experimental treatment)
• capecitabine with bevacizumab (standard treatment)

The main aim of this trial is to find out how well S 95005 and bevacizumab works for people with metastatic bowel cancer.

It is a randomised trial. Everyone taking part is put into 1 of the following treatment groups by computer:
• S 95005 and bevacizumab
• capecitabine and bevacizumab
Neither the patient nor their doctor can choose which group they are in.

Patients will be asked to visit their study doctor for study treatment or follow up for around two-three years, or until the study ends in September 2022, as long as their cancer is not getting worse or they do not have serious side effects.

This is an international phase 3 trial.

Patient Profile

This trial is for people with bowel cancer that has spread to other parts of the body (metastatic). It is for people who:
• are going to have treatment for metastatic bowel cancer for the first time
• can’t have surgery to try to cure their cancer
• can’t have intensive therapy with a combination of chemotherapy drugs

Where’s this trial being run?

Bon Secours Cork, Cork University Hospital, and Tallaght University Hospital

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

Why not Print this page and bring it with you. It will help your doctor and research team advise you.

For more detailed information

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: SOLSTICE
Number: CTRIAL-IE 19-08
Full Title:

An open‐label, randomised, phase III Study comparing trifLuridine/tipiracil (S 95005) in combination with bevacizumab to capecitabine in combination with bevacizumab in first‐line treatment of patients with metastatic colorectal cancer who are not candidate for intensive therapy – SOLSTICE

Principal Investigator:  Professor Ray McDermott
Type: Industry Sponsored
Sponsor:

Institut de Recherches Internationales Servier

Recruitment Started: Global: March 2019
Ireland: April 2019
Global Recruitment Target: 854
Ireland Recruitment Target: 20