• RESOLUTE
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Trial Status

Open

Cancer Type

Colorectal Cancer

If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.

Protocol Title

Randomised Phase II Trial to Evaluate the Strategy of Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer

Purpose of the Study

Bowel cancer is the 2nd leading cause of cancer-related deaths in Australia and one of the leading causes of cancer deaths in individuals under the age of 50. For the majority of patients with advanced or metastatic bowel cancer (cancer that has spread beyond the bowel), standard treatment with systemic treatment (intravenous anti-cancer therapy) can prolong life expectancy, but can never eradicate the cancer and achieve cure. “Oligometastatic cancer” is a relatively recent term that describes a type of metastasis in which cancer cells from the original (primary) tumour travel through the body and form a small number of new tumours (metastatic tumours) in one or two other parts of the body.

The RESOLUTE clinical trial aims to investigate the value of adding local ablative treatment to standard systemic treatment including the impact on survival, compared to continued standard systemic  treatment only, in patients with oligometastatic bowel cancer.

Eligibility Criteria

Key inclusion criteria
  1. Age>=18 years of Age. Both male and female.
  2. Metastatic colorectal adenocarcinoma that is not amenable to potentially curative surgery.
  3. Primary tumour must be controlled if the primary is intact, with no evidence of progression at primary site prior to study entry.
  4. Imaging demonstrating ongoing treatment benefit (partial response or stable disease as per RECIST criteria) after 3-4 months of standard first-line systemic treatment.
  5. 3 to 10 metastatic lesions detected on CT +/- FDG-PET scan prior to first line systemic treatment AND on screening FDG-PET and CT scans:
    o maximum of 3 lesions per organ except for the liver.
    o maximum of 3 involved organs including a lymph node station.
    o only one lymph node station involvement is allowed.
  6. All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.
Key exclusion criteria
  1. 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.
  2. Presence of brain, peritoneal, omental or ovarian metastases.
  3. Malignant pleural effusion or ascites.

Contact Email

resolute@mh.org.au

DETAILED INFORMATION AVAILABLE

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here.

Principal Investigator

Associate Professor Jeanne Tie
Dr Julie Chu

Funding

Cancer Council Victoria

Philanthropic Funding

Patients Recruited

Click here to access the table and view recruitment data on all AGITG open trials:

Open Trial Recruitment Table

Participating Centres

Victoria
Peter MacCallum Cancer Centre

Trial Status

Open

Cancer Type

Colorectal Cancer

If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.

Participating Centres

Victoria
Peter MacCallum Cancer Centre