RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer (RESOLUTE)
Colorectal Cancer, Oligometastatic Disease
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Border Medical OncologyRecruiting
- Bendigo HospitalRecruiting
- Eastern HealthRecruiting
- The Northern Hospital
- St Vincent's Hospital MelbourneRecruiting
- Peter MaCallum Cancer CentreRecruiting
- Peninsula Health
- Western HealthRecruiting
- Northeast Health WangarattaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Local ablative therapies (LAT) arm
Control arm
A 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.
The 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.