Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to either the local ablative therapy (LAT) arm, or the control arm. In the LAT arm, participants will receive metastasis-directed LAT such as radiation therapy or thermal ablation following initial standard first-line systemic treatment. In the control arm, participants will receive continued first-line systemic treatment alone. Those receiving LAT will return to systemic treatment 16 weeks post-randomisation.
Conditions
This trial is treating people with metastatic colorectal cancer
Eligibility
Inclusion
-Metastatic colorectal adenocarcinoma that is not amenable to potentially curative surgery.
-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.
-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.
-All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.
Exclusion
-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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR, ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Cancer Council Victoria
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
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