FOxTROT 2
Status: Open
Title
FOxTROT 2: A phase III trial of neo-adjuvant chemotherapy in older and/or frail patients with locally advanced but resectable colon cancer.
Description
Older patients or those with comorbidity with locally advanced colon cancer (CC), are at a higher risk of postoperative complications or delayed recovery, resulting in frequent delay or omission of postoperative adjuvant chemotherapy (AC). They experience worse CC outcomes than younger patients. This population represents a significant proportion of patients with CC and significant variation has been observed in both rates of major resections and delivery of AC.
We hypothesise that delivery of 6 week neoadjuvant chemotherapy (NAC) will improve outcomes in older patients with locally advanced CC by delivering perioperative benefits of NAC (particularly reduced postop complications), allowing for a period of assessment/ optimization/ prehabilitation and increased delivery of chemotherapy than in adjuvant setting.
Objectives
To assess and compare whether 6 weeks of NAC with oxaliplatin/fluoropyrimidine (OxFp) followed by surgery will improve disease free survival (DFS) and short-term safety and efficacy outcomes in frail and/or older patients compared with straight to surgery (STS).
Trial Design
Randomised, phase III, multi-centre, international, open-label study.
Trial Status
Open
Population
Patients with locally advanced but operable CC who are not suitable for mFOLFOXIRI. Inclusion of patients >70 for whom full dose chemotherapy would be planned is encouraged.
Patients with right sided tumours (proximal to the splenic flexure) will be included if MMR proficient (pMMR)/ microsatellite stable (MSS) status is confirmed. All patients with left-sided tumours can be randomised without mandatory MMR/ microsatellite instability (MSI) testing.