Randomised Phase II Trial to Evaluate the Strategy of Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer (RESOLUTE)

ABSTRACT: Interventions: Local ablative therapy: a maximum of three LAT modalities can be administered for each participant, with a maximum of 2 modalities per organ, provided all LAT can be delivered within 12 weeks and participant can safely resume systemic treatment within 16 weeks from randomisation. LAT modalities allowed include surgical resection, stereotactic radiotherapy (SRT), laparoscopic or percutaneous thermal ablation [radiofrequency ablation (RFA) or microwave ablation (MWA)]. The LAT modalities will be delivered by specialists in the field (surgeons, radiation oncologists and/or interventional radiologists). The precise mode of delivery and number of times the LAT modality is delivered is case-dependent and is determined at a multi-disciplinary meeting (MDM). Resuming previous standard of care first-line systemic treatment: after completing LAT, participant is to resume a further two to three months of first-line systemic treatment to a total of 6 months (including the initial 3-4 months of treatment). For patients receiving a doublet or triplet regimen, treatment may be de-escalated to maintenance fluoropyrimidine +/- biologics or anti-EGFR monotherapy at any point after trial entry at clinician discretion. The treating clinician may choose to discontinue systemic treatment following LAT for patients who have experienced prior intolerable toxicity. Local guidelines will be implemented to ensure intervention fidelity. Case report forms (CRF) specific to each LAT modality will capture specific mode of delivery, organ being treated and number of times the intervention is delivered over a period of time. Primary outcome(s): Efficacy of metastasis-directed local ablative therapies (LAT) following initial standard first-line systemic treatment vs continued first-line systemic treatment alone, as measured by Progression-Free Survival (PFS)[PFS rate (by Investigator) at 12 months from randomisation] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Metastatic Colorectal Cancer,Cancer-bowel-small Bowel (duodenum And Ileum),Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2472791 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR