RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
RESOLUTE
Randomised Phase II Trial to Evaluate Progression-Free Survival in Integrating Local Ablative Therapy With First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
1 other identifier
interventional
75
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Dec 2021
Typical duration for not_applicable colorectal-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2021
CompletedFirst Submitted
Initial submission to the registry
December 8, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2025
CompletedOctober 17, 2023
October 1, 2023
2.5 years
December 8, 2022
October 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
To compare the efficacy of metastasis-directed LAT following initial standard first-line systemic treatment vs continued first-line systemic treatment alone, as measured by Progression-Free Survival (PFS)
12 Months from randomisation
Secondary Outcomes (6)
Overall survival
12 Months from randomisation and through study completion, an average of 1 year
Efficacy of local ablative therapy
12 Months from randomisation and through study completion, an average of 1 year
Time to progression following local ablative therapy
Through study completion, an average of 1 year
Systemic treatment-free interval
Through study completion, an average of 1 year
Rate of high-grade toxicities
Through study completion, an average of 1 year
- +1 more secondary outcomes
Study Arms (2)
Local ablative therapies (LAT) arm
EXPERIMENTALA maximum of three Local ablative therapy (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. 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.
Control arm
PLACEBO COMPARATORThe first-line systemic treatment will be 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Metastatic colorectal adenocarcinoma that is not amenable to potentially oncological curative surgery alone.
- Primary tumour must be controlled if the primary is intact, with no evidence of progression at primary site prior to study entry
- Imaging demonstrating ongoing treatment benefit (partial response or stable disease as per RECIST criteria) after 3-4 months of standard first-line systemic treatment.
- At least one metastatic lesion detected on CT +/- FDG-PET scan prior to first line systemic treatment AND on screening FDG-PET and CT scans, meeting the following criteria:
- max of 3 lesions per organ except for the liver and lung
- max of 5 lesions in the lung
- no limitation to the number of liver lesions provided they are all amenable to LAT
- max of 3 involved organs including a lymph node station
- only one lymph node station involvement is allowed
- for patients with liver metastases, a quadruple phase contrast enhanced CT or MRI liver is required to fully stage the liver; this can be performed prior to or within 4 weeks of commencing first line systemic treatment
- staging FDG-PET scan is encouraged and can be performed prior to or within 4 weeks of commencing first line systemic treatment
- All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.
You may not qualify if:
- Deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-high) tumour
- BRAFV600E mutated tumour
- Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen's disease or prostate cancer with a Gleason score ≤6.
- Presence of brain, peritoneal, omental or ovarian metastases
- Malignant pleural effusion or ascites.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Border Medical Oncology
Albury, New South Wales, 2640, Australia
Bendigo Hospital
Bendigo, Victoria, 3550, Australia
Eastern Health
Box Hill, Victoria, 3128, Australia
The Northern Hospital
Epping, Victoria, 3076, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Peter MaCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Peninsula Health
Rosebud, Victoria, 3940, Australia
Western Health
Saint Albans, Victoria, 3021, Australia
Northeast Health Wangaratta
Wangaratta, Victoria, 3677, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2022
First Posted
May 17, 2023
Study Start
December 14, 2021
Primary Completion
June 14, 2024
Study Completion
June 14, 2025
Last Updated
October 17, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share