Clinical trial NCT05862051: RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Oligometastatic Disease
Lead sponsor: Australasian Gastro-Intestinal Trials Group
Sponsor class: NETWORK
Collaborators: name: Walter and Eliza Hall Institute of Medical Research
name: Cancer Council Victoria
First posted: 2023-05-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 12 Months from randomisation
Secondary outcomes:
measure: Overall survival
timeFrame: 12 Months from randomisation and through study completion, an average of 1 year
measure: Efficacy of local ablative therapy
timeFrame: 12 Months from randomisation and through study completion, an average of 1 year
measure: Time to progression following local ablative therapy
timeFrame: Through study completion, an average of 1 year
measure: Systemic treatment-free interval
timeFrame: Through study completion, an average of 1 year
measure: Rate of high-grade toxicities
timeFrame: Through study completion, an average of 1 year
measure: Quality of life measure
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Albury
country: Australia
facility: Border Medical Oncology
state: New South Wales
city: Bendigo
country: Australia
facility: Bendigo Hospital
state: Victoria
city: Box Hill
country: Australia
facility: Eastern Health
state: Victoria
city: Epping
country: Australia
facility: The Northern Hospital
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: Peter MaCallum Cancer Centre
state: Victoria
city: Rosebud
country: Australia
facility: Peninsula Health
state: Victoria
city: Saint Albans
country: Australia
facility: Western Health
state: Victoria
city: Wangaratta
country: Australia
facility: Northeast Health Wangaratta
state: Victoria
Study officials:
References: