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| Name | Class |
|---|---|
| Walter and Eliza Hall Institute of Medical Research | OTHER |
| Cancer Council Victoria | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local ablative therapies (LAT) arm | Experimental | A maximum of three Local ablative therapy (LAT) modalities can be administered for each participant, with a maximum of 2 modalities per organ, provided all LAT can be delivered within 12 weeks and participant can safely resume systemic treatment within 16 weeks from randomisation. After completing LAT, participant is to resume a further two to three months of first-line systemic treatment to a total of 6 months (including the initial 3-4 months of treatment). 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. The treating clinician may choose to discontinue systemic treatment following LAT for patients who have experienced prior intolerable toxicity. |
|
| Control arm | Placebo Comparator | The first-line systemic treatment will be 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local Ablative Therapy | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 Months from randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 Months from randomisation and through study completion, an average of 1 year |
| Efficacy of local ablative therapy |
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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:
All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Border Medical Oncology | Albury | New South Wales | 2640 | Australia | ||
| Bendigo Hospital |
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| Standard first-line systemic treatment | Procedure | 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. |
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To compare the efficacy of LAT following initial standard first-line systemic treatment, compared to continued first-line systemic treatment alone, on:
|
| 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. | Through study completion, an average of 1 year |
| Systemic treatment-free interval | To compare systemic treatment-free interval between the two treatment groups. | 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. | Through study completion, an average of 1 year |
| Quality 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) | Through study completion, an average of 1 year |
| Bendigo |
| Victoria |
| 3550 |
| Australia |
| Eastern Health | Box Hill | Victoria | 3128 | Australia |
| The Northern Hospital | Epping | Victoria | 3076 | Australia |
| St Vincent's Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Barwon Health | Geelong | Victoria | 3220 | Australia |
| Peter MaCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Western Health | Saint Albans | Victoria | 3021 | Australia |
| Northeast Health Wangaratta | Wangaratta | Victoria | 3677 | Australia |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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