Colorectal CancerRESOLUTENCT05862051
RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
A study testing Local Ablative Therapy and Standard first-line systemic treatment in people with Colorectal Cancer and Oligometastatic Disease, run by Australasian Gastro-Intestinal Trials Group at 9 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Oligometastatic Disease
- What is being tested?
- Local Ablative Therapy and Standard first-line systemic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 9 sitesAustralia
- Study dates
- 14 Dec 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Australia9 sites
Border Medical Oncology
Albury, New South Wales, 2640
Bendigo Hospital
Bendigo, Victoria, 3550
Eastern Health
Box Hill, Victoria, 3128
The Northern Hospital
Epping, Victoria, 3076
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Barwon Health
Geelong, Victoria, 3220
Peter MaCallum Cancer Centre
Melbourne, Victoria, 3000
Western Health
Saint Albans, Victoria, 3021
Northeast Health Wangaratta
Wangaratta, Victoria, 3677
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer, Oligometastatic Disease
- Being tested
- Local Ablative Therapy, Standard first-line systemic treatment
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Ablative TherapyProcedure or surgery
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 treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Local ablative therapies (LAT) arm | Experimental | 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. Receives: Procedure: Local Ablative Therapy; Procedure: Standard first-line systemic treatment |
| Control arm | Placebo comparator | 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. Receives: Procedure: Standard first-line systemic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 Months from randomisation
Secondary outcomes (6)
Overall survival
To compare the efficacy of LAT following initial standard first-line systemic treatment, compared to continued first-line systemic treatment alone, as measured by Overall Survival (OS)
Measured: 12 Months from randomisation and through study completion, an average of 1 year
Efficacy of local ablative therapy
To compare the efficacy of LAT following initial standard first-line systemic treatment, compared to continued first-line systemic treatment alone, on:
- time to development of new metastatic lesions.
- time to initiation of 2nd line systemic treatment.
Measured: 12 Months from randomisation and through study completion, an average of 1 year
Time to progression following local ablative therapy
To assess the time to progression of LAT treated lesions.
Measured: Through study completion, an average of 1 year
Systemic treatment-free interval
To compare systemic treatment-free interval between the two treatment groups.
Measured: Through study completion, an average of 1 year
Rate of high-grade toxicities
To assess and compare rate of high-grade (Grade 3-5) toxicities between the two treatment groups.
Measured: Through study completion, an average of 1 year
Quality of life measure
To compare quality of life measures between the two treatment groups using patient questionnaire - The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) using the 4-point ordinal scale (not at all, a little, quite a bit and very much)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start14 Dec 2021
- Primary completion31 Dec 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australasian Gastro-Intestinal Trials Group
- Sponsor type
- Research network
- Collaborators
- Walter and Eliza Hall Institute of Medical Research, Cancer Council Victoria
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862051
- Sponsor's protocol ID
- RESOLUTE
- Acronym
- RESOLUTE
- Status last verified
- May 2026
- First submitted
- 8 Dec 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05862051
- Acronym / sponsor ID
- RESOLUTE / RESOLUTE
- Conditions
- Colorectal Cancer, Oligometastatic Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Australasian Gastro-Intestinal Trials GroupResearch network
- Collaborators
- Walter and Eliza Hall Institute of Medical Research, Cancer Council Victoria
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local ablative therapies (LAT) arm | Experimental | Procedure: Local Ablative Therapy, Procedure: Standard first-line systemic treatmentA 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 comparator | Procedure: Standard first-line systemic treatmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local Ablative TherapyLAT 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 or surgery | Local ablative therapies (LAT) arm |
| Standard first-line systemic treatmentStandard 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. | Procedure or surgery | Control arm, Local ablative therapies (LAT) arm |
Primary outcome
Progression free survival (PFS)
Time frame: 12 Months from randomisation
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)
6 secondary outcomes
Overall survival
Time frame: 12 Months from randomisation and through study completion, an average of 1 year
Efficacy of local ablative therapy
Time frame: 12 Months from randomisation and through study completion, an average of 1 year
Time to progression following local ablative therapy
Time frame: Through study completion, an average of 1 year
Systemic treatment-free interval
Time frame: Through study completion, an average of 1 year
Rate of high-grade toxicities
Time frame: Through study completion, an average of 1 year
Quality of life measure
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Ablative Therapy and Standard first-line systemic treatment in people with Colorectal Cancer and Oligometastatic Disease, run by Australasian Gastro-Intestinal Trials Group at 9 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 12 Months from randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.