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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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).
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.
Border Medical Oncology
Albury, New South Wales, Australia
RECRUITINGBendigo Hospital
Bendigo, Victoria, Australia
RECRUITINGEastern Health
Box Hill, Victoria, Australia
Progression free survival (PFS)
To compare the efficacy of metastasis-directed LAT following initial standard first-line systemic treatment vs continued first-line systemic treatment alone, as measured by Progression-Free Survival (PFS)
Time frame: 12 Months from randomisation
Overall survival
To compare the efficacy of LAT following initial standard first-line systemic treatment, compared to continued first-line systemic treatment alone, as measured by Overall Survival (OS)
Time frame: 12 Months from randomisation and through study completion, an average of 1 year
Efficacy of local ablative therapy
To compare the efficacy of LAT following initial standard first-line systemic treatment, compared to continued first-line systemic treatment alone, on: 1. time to development of new metastatic lesions. 2. time to initiation of 2nd line systemic treatment.
Time frame: 12 Months from randomisation and through study completion, an average of 1 year
Time to progression following local ablative therapy
To assess the time to progression of LAT treated lesions.
Time frame: Through study completion, an average of 1 year
Systemic treatment-free interval
To compare systemic treatment-free interval between the two treatment groups.
Time frame: Through study completion, an average of 1 year
Rate of high-grade toxicities
To assess and compare rate of high-grade (Grade 3-5) toxicities between the two treatment groups.
Time frame: Through study completion, an average of 1 year
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The Northern Hospital
Epping, Victoria, Australia
NOT_YET_RECRUITINGSt Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
RECRUITINGPeter MaCallum Cancer Centre
Melbourne, Victoria, Australia
RECRUITINGPeninsula Health
Rosebud, Victoria, Australia
NOT_YET_RECRUITINGWestern Health
Saint Albans, Victoria, Australia
RECRUITINGNortheast Health Wangaratta
Wangaratta, Victoria, Australia
RECRUITINGQuality of life measure
To compare quality of life measures between the two treatment groups using patient questionnaire - The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) using the 4-point ordinal scale (not at all, a little, quite a bit and very much)
Time frame: Through study completion, an average of 1 year