FOxTROT - Personalising neo-adjuvant Chemotherapy in Locally advanced but operable colon cancer.
Research type
Research Study
Full title
FOxTROT Trial Platform: Personalising neo-adjuvant Chemotherapy in Locally advanced but operable colon cancer. A randomised trial platform.
IRAS ID
1003812
Contact name
Clare Skinner
Contact email
Sponsor organisation
University of Leeds
Eudract number
2021-002216-31
ISRCTN Number
ISRCTN83842641
Research summary
After lung cancer, bowel (colorectal) cancer is the next most common cause of cancer death in the UK. Doctors usually treat bowel cancer with surgery often followed by chemotherapy to help stop the cancer coming back. Despite all of the medical advances in recent years, until recently there have been no significant improvements to this treatment approach.
However, an international research trial (FOxTROT1) showed that having some chemotherapy (using the normal chemotherapy drugs for bowel cancer) before surgery (known as neoadjuvant chemotherapy), was safe and reduced the chances of the cancer coming back. However, patients in this study were mainly young and fit.
This important study will now be extended to improve and personalise this new patient pathway.
This is a platform study, which means there will be several trial comparisons each looking at different treatment combinations.
FOxTROT 2 will open first to see whether this order of treatment is effective with gentler neoadjuvant chemotherapy before surgery in older patients or those with other medical problems. This will be compared to the standard treatment of surgery first. Patients will be randomly allocated to either the new approach (neoadjuvant chemotherapy) or standard treatment.
FOxTROT 3 will open next and is a trial for younger, fitter patients. FT3 will be added in as a substantial amendment. Preliminary detail for FT3 is given in the master protocol. More comparisons will be added to look at targeted drug combinations, immune oncology and guided post-operative treatment. The design means trial comparisons can be added easily as new combinations become available.REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0277
Date of REC Opinion
26 Oct 2021
REC opinion
Further Information Favourable Opinion