Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863351
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-05-08
Brief Title:
Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis SOAR Study
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase III Randomized Trial of Stereotactic Ablative Radiotherapy SAbR for Oligometastatic Advanced Renal Carcinoma SOAR
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial compares the effect of stero-ablative radiotherapy SAbR followed by standard of care systemic therapy to standard of care systemic therapy alone in patients with kidney cancer that has spread from where it first started primary site to a limited 2-5 number of places in the body metastatic Study doctors want to find out if this approach is better or worse than the usual approach for metastatic kidney cancer The usual approach is defined as the care most people get for metastatic kidney cancer which includes systemic therapy such as immunotherapy given through the veins andor small molecular inhibitor tablets taken by mouth Radiotherapy uses high energy x-rays to kill cancer cells and shrink tumors SAbR uses special equipment to position a patient and deliver radiation to tumors with high precision Giving SAbR prior to systemic therapy may kill more tumor cells than the usual approach which is systemic therapy alone
Detailed Description:
PRIMARY OBJECTIVES
I To compare overall survival OS between patients receiving SAbR systemic therapy SABRST versus systemic therapy ST only
II To compare average adverse event AE score between SAbRST arm and ST only arm
SECONDARY OBJECTIVES
I To compare global health status quality of life QOL between patients receiving SAbRST versus ST only
II To compare progression-free survival PFS between the arms
EXPLORATORY OBJECTIVES
I To estimate PFS on first line systemic therapy PFS-SST in the SAbRST arm and compare with first line systemic therapy PFS of the ST arm
II To explore local control from SAbR by looking at the amount of local failures after SAbR in the SAbRST arm
III To assess the cost-effectiveness between the arms in terms of cost per unit gain in quality-of-life years
QOL OBJECTIVES
I To compare global health status quality of life QOL between patients receiving SabRST versus ST only using the National Comprehensive Cancer Network NCCN Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index -19 item NFKSI-19
II To compare quality-adjusted survival between patients randomized to receive SabRST vs ST alone using European Quality of Life EUROQOL 5-dimension 5-level EQ-5D-5L at 3 6 9 12 18 and 24 months
III To compare global health status QOL of the NFKSI-19 at all of the 3 6 9 12 18 and 24 month time points between patients randomized to receive SabRST versus ST alone
IV To compare scale scores of the NFKSI-19 disease-related symptoms - physical disease-related symptoms - emotional treatment side effects and function well-being at 3 6 9 12 18 24 months between patients randomized to receive SabRST versus ST alone
V To compare time to global quality of life deterioration between patients randomized to receive SabRST versus ST alone using NFKSI-19
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive standard of care systemic therapy on study
ARM II Patients undergo repeated SAbR until progression and then receive standard of care systemic therapy on study
Patients in both arms undergo computed tomography CT or magnetic resonance imaging MRI throughout the trial
I To compare overall survival OS between patients receiving SAbR systemic therapy SABRST versus systemic therapy ST only
II To compare average adverse event AE score between SAbRST arm and ST only arm
SECONDARY OBJECTIVES
I To compare global health status quality of life QOL between patients receiving SAbRST versus ST only
II To compare progression-free survival PFS between the arms
EXPLORATORY OBJECTIVES
I To estimate PFS on first line systemic therapy PFS-SST in the SAbRST arm and compare with first line systemic therapy PFS of the ST arm
II To explore local control from SAbR by looking at the amount of local failures after SAbR in the SAbRST arm
III To assess the cost-effectiveness between the arms in terms of cost per unit gain in quality-of-life years
QOL OBJECTIVES
I To compare global health status quality of life QOL between patients receiving SabRST versus ST only using the National Comprehensive Cancer Network NCCN Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index -19 item NFKSI-19
II To compare quality-adjusted survival between patients randomized to receive SabRST vs ST alone using European Quality of Life EUROQOL 5-dimension 5-level EQ-5D-5L at 3 6 9 12 18 and 24 months
III To compare global health status QOL of the NFKSI-19 at all of the 3 6 9 12 18 and 24 month time points between patients randomized to receive SabRST versus ST alone
IV To compare scale scores of the NFKSI-19 disease-related symptoms - physical disease-related symptoms - emotional treatment side effects and function well-being at 3 6 9 12 18 24 months between patients randomized to receive SabRST versus ST alone
V To compare time to global quality of life deterioration between patients randomized to receive SabRST versus ST alone using NFKSI-19
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive standard of care systemic therapy on study
ARM II Patients undergo repeated SAbR until progression and then receive standard of care systemic therapy on study
Patients in both arms undergo computed tomography CT or magnetic resonance imaging MRI throughout the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-02060 | REGISTRY | None | None |
| EA8211 | OTHER | None | None |
| EA8211 | OTHER | None | None |
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |