Trial Title:
RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
NCT ID:
NCT05862051
Condition:
Colorectal Cancer
Oligometastatic Disease
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Local Ablative Therapy
Description:
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).
Arm group label:
Local ablative therapies (LAT) arm
Intervention type:
Procedure
Intervention name:
Standard first-line systemic treatment
Description:
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.
Arm group label:
Control arm
Arm group label:
Local ablative therapies (LAT) arm
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.
Detailed description:
Who is this study for:
Adults with unresectable oligo-metastatic colorectal who have demonstrated treatment
benefit (partial response or stable disease as per RECIST criteria) after 3-4 months of
standard first-line systemic treatment.
Study details
Participants will be randomly allocated to either a LAT arm, who will receive
metastasis-directed LAT such as radiotherapy or thermal ablation following initial
standard first-line systemic treatment, or a control arm who will receive continued
first-line systemic treatment alone. Those receiving LAT will return to systemic
treatment 16 weeks post-randomisation. Information on progression-free survival and
treatment outcomes will be collected.
Data from this study will inform investigators of the potential benefit of local ablative
therapy in the therapeutic setting for metastatic colorectal cancer.
Criteria for 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:
1. max of 3 lesions per organ except for the liver and lung
2. max of 5 lesions in the lung
3. no limitation to the number of liver lesions provided they are all amenable to
LAT
4. max of 3 involved organs including a lymph node station
5. only one lymph node station involvement is allowed
6. 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
7. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Border Medical Oncology
Address:
City:
Albury
Zip:
2640
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jacqui Mcburnie
Email:
Jacqui.Mcburnie@bordermedonc.com.au
Facility:
Name:
Bendigo Hospital
Address:
City:
Bendigo
Zip:
3550
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Narelle McPhee
Email:
NMcPhee@bendigohealth.org.au
Facility:
Name:
Eastern Health
Address:
City:
Box Hill
Zip:
3128
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Rachel Wong
Email:
Rachel.Wong@monash.edu
Facility:
Name:
The Northern Hospital
Address:
City:
Epping
Zip:
3076
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Karen Matoga
Email:
Karen.Matoga2@nh.org.au
Facility:
Name:
St Vincent's Hospital Melbourne
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Nadia Ranieri
Email:
Nadia.ranieri@svha.org.au
Facility:
Name:
Peter MaCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Marie Luci
Email:
marie.luci@ctaust.org
Investigator:
Last name:
Jeanne Tie
Email:
Principal Investigator
Facility:
Name:
Peninsula Health
Address:
City:
Rosebud
Zip:
3940
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Sally Heath
Email:
sallyheath@phcn.vic.gov.au
Facility:
Name:
Western Health
Address:
City:
Saint Albans
Zip:
3021
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Stephanie Henderson
Email:
Stephanie.Henderson@ctaust.org
Facility:
Name:
Northeast Health Wangaratta
Address:
City:
Wangaratta
Zip:
3677
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Nicole Humphreys
Email:
Nicole.Humphreys@nhw.org.au
Start date:
December 14, 2021
Completion date:
June 14, 2025
Lead sponsor:
Agency:
Australasian Gastro-Intestinal Trials Group
Agency class:
Other
Collaborator:
Agency:
Walter and Eliza Hall Institute of Medical Research
Agency class:
Other
Collaborator:
Agency:
Cancer Council Victoria
Agency class:
Other
Source:
Australasian Gastro-Intestinal Trials Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05862051
