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ACTIVE NOT RECRUITING
NCT05862051
NA

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

Sponsor: Australasian Gastro-Intestinal Trials Group

View on ClinicalTrials.gov

Summary

This study aims to assess the clinical benefit of local ablative therapy (LAT) following initial standard first-line systemic treatment including the impact on survival, compared to continued standard first-line systemic treatment for oligometastatic colorectal cancer.

Official title: Randomised Phase II Trial to Evaluate Progression-Free Survival in Integrating Local Ablative Therapy With First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2021-12-14

Completion Date

2027-12

Last Updated

2026-05-08

Healthy Volunteers

No

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.

Locations (9)

Border Medical Oncology

Albury, New South Wales, Australia

Bendigo Hospital

Bendigo, Victoria, Australia

Eastern Health

Box Hill, Victoria, Australia

The Northern Hospital

Epping, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Barwon Health

Geelong, Victoria, Australia

Peter MaCallum Cancer Centre

Melbourne, Victoria, Australia

Western Health

Saint Albans, Victoria, Australia

Northeast Health Wangaratta

Wangaratta, Victoria, Australia