RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer

NARecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

December 14, 2021

Primary Completion Date

June 14, 2024

Study Completion Date

June 14, 2025

Conditions
Colorectal CancerOligometastatic Disease
Interventions
PROCEDURE

Local Ablative Therapy

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).

PROCEDURE

Standard first-line systemic treatment

Standard of care as determined by the treating clinician. The following standard chemotherapy regimens are allowed: single agent fluoropyrimidine, CAPOX, FOLFOX, FOLFIRI, CAPIRI or FOLFOXIRI. Treatment with a biologic is allowed including bevacizumab or an anti-EGFR antibody (cetuximab or panitumumab). 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.

Trial Locations (9)

2640

RECRUITING

Border Medical Oncology, Albury

3000

RECRUITING

Peter MaCallum Cancer Centre, Melbourne

3021

RECRUITING

Western Health, Saint Albans

3065

RECRUITING

St Vincent's Hospital Melbourne, Fitzroy

3076

NOT_YET_RECRUITING

The Northern Hospital, Epping

3128

RECRUITING

Eastern Health, Box Hill

3550

RECRUITING

Bendigo Hospital, Bendigo

3677

RECRUITING

Northeast Health Wangaratta, Wangaratta

3940

NOT_YET_RECRUITING

Peninsula Health, Rosebud

All Listed Sponsors
collaborator

Walter and Eliza Hall Institute of Medical Research

OTHER

collaborator

Cancer Council Victoria

OTHER

lead

Australasian Gastro-Intestinal Trials Group

NETWORK