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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
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
Conditions
Interventions
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).
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