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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05862051




Registration number
NCT05862051
Ethics application status
Date submitted
8/12/2022
Date registered
17/05/2023
Date last updated
17/10/2023

Titles & IDs
Public title
RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
Scientific 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
Secondary ID [1] 0 0
RESOLUTE
Universal Trial Number (UTN)
Trial acronym
RESOLUTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Oligometastatic Disease 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Local Ablative Therapy
Treatment: Surgery - Standard first-line systemic treatment

Experimental: Local ablative therapies (LAT) 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.

Placebo Comparator: Control arm - 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.


Treatment: Surgery: 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).

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS)
Timepoint [1] 0 0
12 Months from randomisation
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
12 Months from randomisation and through study completion, an average of 1 year
Secondary outcome [2] 0 0
Efficacy of local ablative therapy
Timepoint [2] 0 0
12 Months from randomisation and through study completion, an average of 1 year
Secondary outcome [3] 0 0
Time to progression following local ablative therapy
Timepoint [3] 0 0
Through study completion, an average of 1 year
Secondary outcome [4] 0 0
Systemic treatment-free interval
Timepoint [4] 0 0
Through study completion, an average of 1 year
Secondary outcome [5] 0 0
Rate of high-grade toxicities
Timepoint [5] 0 0
Through study completion, an average of 1 year
Secondary outcome [6] 0 0
Quality of life measure
Timepoint [6] 0 0
Through study completion, an average of 1 year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/06/2025
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [3] 0 0
Eastern Health - Box Hill
Recruitment hospital [4] 0 0
The Northern Hospital - Epping
Recruitment hospital [5] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Peter MaCallum Cancer Centre - Melbourne
Recruitment hospital [7] 0 0
Peninsula Health - Rosebud
Recruitment hospital [8] 0 0
Western Health - Saint Albans
Recruitment hospital [9] 0 0
Northeast Health Wangaratta - Wangaratta
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
3550 - Bendigo
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3076 - Epping
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
3940 - Rosebud
Recruitment postcode(s) [8] 0 0
3021 - Saint Albans
Recruitment postcode(s) [9] 0 0
3677 - Wangaratta

Funding & Sponsors
Primary sponsor type
Other
Name
Australasian Gastro-Intestinal Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Walter and Eliza Hall Institute of Medical Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cancer Council Victoria
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT05862051
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sukanya Sathyamurthie
Address 0 0
Country 0 0
Phone 0 0
+61 2 7208 2719
Fax 0 0
Email 0 0
sukanya@gicancer.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05862051