RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer

Last updated: October 15, 2023
Sponsor: Australasian Gastro-Intestinal Trials Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Colon Cancer

Colon Cancer; Rectal Cancer

Treatment

Local Ablative Therapy

Standard first-line systemic treatment

Clinical Study ID

NCT05862051
RESOLUTE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Metastatic colorectal adenocarcinoma that is not amenable to potentially oncologicalcurative surgery alone.
  • Primary tumour must be controlled if the primary is intact, with no evidence ofprogression at primary site prior to study entry
  • Imaging demonstrating ongoing treatment benefit (partial response or stable disease asper 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 linesystemic treatment AND on screening FDG-PET and CT scans, meeting the followingcriteria:
  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 toLAT
  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 MRIliver is required to fully stage the liver; this can be performed prior to orwithin 4 weeks of commencing first line systemic treatment
  7. staging FDG-PET scan is encouraged and can be performed prior to or within 4weeks of commencing first line systemic treatment
  • All lesions can be safely treated by LAT as determined by multidisciplinary teammeeting.

Exclusion

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, exceptcuratively treated basal or squamous cell skin cancer, prostate intraepithelialneoplasm, carcinoma in-situ of the cervix, Bowen's disease or prostate cancer with aGleason score ≤6.
  • Presence of brain, peritoneal, omental or ovarian metastases
  • Malignant pleural effusion or ascites.

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Local Ablative Therapy
Phase:
Study Start date:
December 14, 2021
Estimated Completion Date:
June 14, 2025

Study 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.

Connect with a study center

  • Border Medical Oncology

    Albury, New South Wales 2640
    Australia

    Active - Recruiting

  • Bendigo Hospital

    Bendigo, Victoria 3550
    Australia

    Active - Recruiting

  • Eastern Health

    Box Hill, Victoria 3128
    Australia

    Active - Recruiting

  • The Northern Hospital

    Epping, Victoria 3076
    Australia

    Site Not Available

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Peter MaCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Peninsula Health

    Rosebud, Victoria 3940
    Australia

    Site Not Available

  • Western Health

    Saint Albans, Victoria 3021
    Australia

    Active - Recruiting

  • Northeast Health Wangaratta

    Wangaratta, Victoria 3677
    Australia

    Active - Recruiting

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