Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study
Purpose
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) and/or 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.
Conditions
- Metastatic Renal Cell Carcinoma
- Stage IV Renal Cell Cancer AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patient must be >= 18 years of age - Patient must have a pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma (RCC) prior to randomization - Patient may have any RCC histology except a histology that has a sarcomatoid component - Patient must have primary site addressed by local therapy. If the primary RCC is intact, the patient must undergo local treatment to the primary before randomization - Patient must have favorable or intermediate International Metastatic RCC Database Consortium (IMDC) risk (0-2) at the time of randomization - Patient must have a total of between 2 and 5 metastatic lesions, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria with imaging obtained within 45 days prior to randomization - Patient must have a documentation from a radiation oncologist confirming that all sites are amenable to SAbR - Patient may have received prior therapy in the adjuvant setting as long as potential trial participants have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better - All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy - A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: - Has achieved menarche at some point - Has not undergone a hysterectomy or bilateral oophorectomy - Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) - Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible - Patient must have a Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 - Patients must have adequate organ and bone marrow function as per the recommended guidelines and the respective Food and Drug Administration [FDA] package insert required for the systemic therapy chosen by the treating oncologist. We recognize that patients may have varying levels of renal and liver function that will impact which systemic therapy is appropriate for the patient. We do not require all patients to have specific baseline laboratory thresholds but do ask the treating oncologist to attest that the patient has adequate organ and bone marrow function to safely receive one of the first line systemic therapies listed in the protocol as a standard of care treatment option - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for entry onto the study - For patients with history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. If no previous history, testing for HBV is not required for entry onto the study - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. If no previous history, testing for HCV is not required for entry onto the study - In order to participate in the QOL portion of the protocol, the patient must speak one of the languages in which the NFKSI-19 and EQ-5D-5L is available - NOTE: Sites cannot translate the associated QOL forms
Exclusion Criteria
- Patient must not have brain metastases - Patient must not have metastasis involving the following locations: ultra-central (within 2cm of carina) lung, invading gastrointestinal tract (such as esophagus, stomach, intestines, colon, rectum), skin, and scalp - Patient must not have received any prior systemic therapy (except for adjuvant setting) for metastatic RCC - Active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease - History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies - Active tuberculosis (purified protein derivative [PPD] response without active TB is allowed) - Uncontrolled hypertension (systolic blood pressure [BP] > 190mmHg or diastolic BP > 110mmHg) - Major surgery within 30 days prior to randomization - Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer, or bone fracture within 30 days prior to randomization - Any arterial thrombotic (ST elevation myocardial infarction [STEMI], non-STEMI [NSTEMI], cerebrovascular accident [CVA], etc.) events within 180 days prior to randomization - Moderate or severe hepatic impairment (child-Pugh B or C) - Untreated pulmonary embolism (PE) or deep-vein thrombosis (DVT) is not allowed. Treated PE or DVT is allowed > 30 days from diagnosis and when not resulting in respiratory impairment - Unstable cardiac arrhythmia within 180 days prior to randomization - History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to randomization - History of or active inflammatory bowel disease - Malabsorption syndrome within 30 days prior to randomization - Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used - Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm I (usual care) |
Patients receive standard of care systemic therapy on study. Patients undergo CT or MRI throughout the trial. |
|
|
Experimental Arm II (SAbR, usual care) |
Patients undergo repeated SAbR until progression and then receive standard of care systemic therapy on study. Patients undergo CT or MRI throughout the trial. |
|
Recruiting Locations
Mayo Clinic Hospital in Arizona
Phoenix 5308655, Arizona 5551752 85054
Phoenix 5308655, Arizona 5551752 85054
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
UCHealth University of Colorado Hospital
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Contact:
Site Public Contact
720-848-0650
Site Public Contact
720-848-0650
Poudre Valley Hospital
Fort Collins 5577147, Colorado 5417618 80524
Fort Collins 5577147, Colorado 5417618 80524
Contact:
Site Public Contact
970-297-6150
Site Public Contact
970-297-6150
Cancer Care and Hematology-Fort Collins
Fort Collins 5577147, Colorado 5417618 80528
Fort Collins 5577147, Colorado 5417618 80528
UCHealth Greeley Hospital
Greeley 5577592, Colorado 5417618 80631
Greeley 5577592, Colorado 5417618 80631
UCHealth Highlands Ranch Hospital
Highlands Ranch 5425043, Colorado 5417618 80129
Highlands Ranch 5425043, Colorado 5417618 80129
Contact:
Site Public Contact
720-848-0650
Site Public Contact
720-848-0650
Medical Center of the Rockies
Loveland 5579368, Colorado 5417618 80538
Loveland 5579368, Colorado 5417618 80538
Contact:
Site Public Contact
970-203-7083
Site Public Contact
970-203-7083
Sibley Memorial Hospital
Washington D.C. 4140963, District of Columbia 4138106 20016
Washington D.C. 4140963, District of Columbia 4138106 20016
Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751 32224-9980
Jacksonville 4160021, Florida 4155751 32224-9980
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
OSF Saint Joseph Medical Center
Bloomington 4885164, Illinois 4896861 61701
Bloomington 4885164, Illinois 4896861 61701
Illinois CancerCare-Bloomington
Bloomington 4885164, Illinois 4896861 61704
Bloomington 4885164, Illinois 4896861 61704
Illinois CancerCare-Canton
Canton 4831990, Illinois 4896861 61520
Canton 4831990, Illinois 4896861 61520
Illinois CancerCare-Carthage
Carthage 4886716, Illinois 4896861 62321
Carthage 4886716, Illinois 4896861 62321
Centralia Oncology Clinic
Centralia 4235587, Illinois 4896861 62801
Centralia 4235587, Illinois 4896861 62801
Northwestern University
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
University of Illinois
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60612
Contact:
Site Public Contact
312-355-3046
Site Public Contact
312-355-3046
Carle at The Riverfront
Danville 4889426, Illinois 4896861 61832
Danville 4889426, Illinois 4896861 61832
Cancer Care Specialists of Illinois - Decatur
Decatur 4236895, Illinois 4896861 62526
Decatur 4236895, Illinois 4896861 62526
Decatur Memorial Hospital
Decatur 4236895, Illinois 4896861 62526
Decatur 4236895, Illinois 4896861 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb 4889553, Illinois 4896861 60115
DeKalb 4889553, Illinois 4896861 60115
Carle Physician Group-Effingham
Effingham 4237727, Illinois 4896861 62401
Effingham 4237727, Illinois 4896861 62401
Crossroads Cancer Center
Effingham 4237727, Illinois 4896861 62401
Effingham 4237727, Illinois 4896861 62401
Illinois CancerCare-Eureka
Eureka 4891310, Illinois 4896861 61530
Eureka 4891310, Illinois 4896861 61530
Illinois CancerCare-Galesburg
Galesburg 4893392, Illinois 4896861 61401
Galesburg 4893392, Illinois 4896861 61401
Northwestern Medicine Cancer Center Delnor
Geneva 4893591, Illinois 4896861 60134
Geneva 4893591, Illinois 4896861 60134
Illinois CancerCare-Kewanee Clinic
Kewanee 4898433, Illinois 4896861 61443
Kewanee 4898433, Illinois 4896861 61443
Illinois CancerCare-Macomb
Macomb 4900817, Illinois 4896861 61455
Macomb 4900817, Illinois 4896861 61455
Carle Physician Group-Mattoon/Charleston
Mattoon 4244099, Illinois 4896861 61938
Mattoon 4244099, Illinois 4896861 61938
Cancer Care Center of O'Fallon
O'Fallon 4245926, Illinois 4896861 62269
O'Fallon 4245926, Illinois 4896861 62269
HSHS Saint Elizabeth's Hospital
O'Fallon 4245926, Illinois 4896861 62269
O'Fallon 4245926, Illinois 4896861 62269
Illinois CancerCare-Ottawa Clinic
Ottawa 4905006, Illinois 4896861 61350
Ottawa 4905006, Illinois 4896861 61350
Illinois CancerCare-Pekin
Pekin 4905599, Illinois 4896861 61554
Pekin 4905599, Illinois 4896861 61554
Illinois CancerCare-Peoria
Peoria 4905687, Illinois 4896861 61615
Peoria 4905687, Illinois 4896861 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria 4905687, Illinois 4896861 61615
Peoria 4905687, Illinois 4896861 61615
OSF Saint Francis Medical Center
Peoria 4905687, Illinois 4896861 61637
Peoria 4905687, Illinois 4896861 61637
Illinois CancerCare-Peru
Peru 4905770, Illinois 4896861 61354
Peru 4905770, Illinois 4896861 61354
Illinois CancerCare-Princeton
Princeton 4906818, Illinois 4896861 61356
Princeton 4906818, Illinois 4896861 61356
Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62702
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield 4250542, Illinois 4896861 62702
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Memorial Medical Center
Springfield 4250542, Illinois 4896861 62781
Springfield 4250542, Illinois 4896861 62781
Carle Cancer Center
Urbana 4914570, Illinois 4896861 61801
Urbana 4914570, Illinois 4896861 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville 4915525, Illinois 4896861 60555
Warrenville 4915525, Illinois 4896861 60555
Illinois CancerCare - Washington
Washington 4915545, Illinois 4896861 61571
Washington 4915545, Illinois 4896861 61571
Mary Greeley Medical Center
Ames 4846834, Iowa 4862182 50010
Ames 4846834, Iowa 4862182 50010
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Ames
Ames 4846834, Iowa 4862182 50010
Ames 4846834, Iowa 4862182 50010
Mission Cancer and Blood - Ankeny
Ankeny 4846960, Iowa 4862182 50023
Ankeny 4846960, Iowa 4862182 50023
Contact:
Site Public Contact
515-282-2921
Site Public Contact
515-282-2921
Mercy Hospital
Cedar Rapids 4850751, Iowa 4862182 52403
Cedar Rapids 4850751, Iowa 4862182 52403
Contact:
Site Public Contact
319-365-4673
Site Public Contact
319-365-4673
Oncology Associates at Mercy Medical Center
Cedar Rapids 4850751, Iowa 4862182 52403
Cedar Rapids 4850751, Iowa 4862182 52403
Contact:
Site Public Contact
319-363-2690
Site Public Contact
319-363-2690
Mission Cancer and Blood - West Des Moines
Clive 4852065, Iowa 4862182 50325
Clive 4852065, Iowa 4862182 50325
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Iowa Methodist Medical Center
Des Moines 4853828, Iowa 4862182 50309
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-6727
Site Public Contact
515-241-6727
Mission Cancer and Blood - Des Moines
Des Moines 4853828, Iowa 4862182 50309
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Mission Cancer and Blood - Laurel
Des Moines 4853828, Iowa 4862182 50314
Des Moines 4853828, Iowa 4862182 50314
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
University of Kansas Clinical Research Center
Fairway 4271358, Kansas 4273857 66205
Fairway 4271358, Kansas 4273857 66205
University of Kansas Cancer Center
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
Olathe Health Cancer Center
Olathe 4276614, Kansas 4273857 66061
Olathe 4276614, Kansas 4273857 66061
University of Kansas Cancer Center-Overland Park
Overland Park 4276873, Kansas 4273857 66210
Overland Park 4276873, Kansas 4273857 66210
University of Kansas Hospital-Indian Creek Campus
Overland Park 4276873, Kansas 4273857 66211
Overland Park 4276873, Kansas 4273857 66211
Salina Regional Health Center
Salina 4278890, Kansas 4273857 67401
Salina 4278890, Kansas 4273857 67401
University of Kansas Health System Saint Francis Campus
Topeka 4280539, Kansas 4273857 66606
Topeka 4280539, Kansas 4273857 66606
Contact:
Site Public Contact
785-295-8000
Site Public Contact
785-295-8000
University of Kansas Hospital-Westwood Cancer Center
Westwood 4281639, Kansas 4273857 66205
Westwood 4281639, Kansas 4273857 66205
The James Graham Brown Cancer Center at University of Louisville
Louisville 4299276, Kentucky 6254925 40202
Louisville 4299276, Kentucky 6254925 40202
Contact:
Site Public Contact
502-562-3429
Site Public Contact
502-562-3429
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore 4347778, Maryland 4361885 21287
Baltimore 4347778, Maryland 4361885 21287
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor 4984247, Michigan 5001836 48106
Ann Arbor 4984247, Michigan 5001836 48106
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48114
Trinity Health Medical Center - Brighton
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48114
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton 4987990, Michigan 5001836 48188
Canton 4987990, Michigan 5001836 48188
Trinity Health Medical Center - Canton
Canton 4987990, Michigan 5001836 48188
Canton 4987990, Michigan 5001836 48188
Chelsea Hospital
Chelsea 4988628, Michigan 5001836 48118
Chelsea 4988628, Michigan 5001836 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea 4988628, Michigan 5001836 48118
Chelsea 4988628, Michigan 5001836 48118
University of Michigan Health - Sparrow Lansing
Lansing 4998830, Michigan 5001836 48912
Lansing 4998830, Michigan 5001836 48912
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia 4999837, Michigan 5001836 48154
Livonia 4999837, Michigan 5001836 48154
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti 5015688, Michigan 5001836 48197
Ypsilanti 5015688, Michigan 5001836 48197
Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
Saint Francis Medical Center
Cape Girardeau 4379966, Missouri 4398678 63703
Cape Girardeau 4379966, Missouri 4398678 63703
University of Kansas Cancer Center - North
Kansas City 4393217, Missouri 4398678 64154
Kansas City 4393217, Missouri 4398678 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit 4394870, Missouri 4398678 64064
Lee's Summit 4394870, Missouri 4398678 64064
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City 4400860, Missouri 4398678 64116
North Kansas City 4400860, Missouri 4398678 64116
Mercy Hospital Springfield
Springfield 4409896, Missouri 4398678 65804
Springfield 4409896, Missouri 4398678 65804
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Mercy Hospital South
St Louis 4407066, Missouri 4398678 63128
St Louis 4407066, Missouri 4398678 63128
Mercy Hospital Saint Louis
St Louis 4407066, Missouri 4398678 63141
St Louis 4407066, Missouri 4398678 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Bozeman Health Deaconess Hospital
Bozeman 5641727, Montana 5667009 59715
Bozeman 5641727, Montana 5667009 59715
Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638 14263
Buffalo 5110629, New York 5128638 14263
Northwell Health/Center for Advanced Medicine
Lake Success 5123853, New York 5128638 11042
Lake Success 5123853, New York 5128638 11042
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
Lenox Hill Hospital
New York 5128581, New York 5128638 10021
New York 5128581, New York 5128638 10021
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
Manhattan Eye Ear and Throat Hospital
New York 5128581, New York 5128638 10065
New York 5128581, New York 5128638 10065
Contact:
Site Public Contact
212-434-4460
Site Public Contact
212-434-4460
Highland Hospital
Rochester 5134086, New York 5128638 14620
Rochester 5134086, New York 5128638 14620
Contact:
Site Public Contact
585-341-8113
Site Public Contact
585-341-8113
University of Rochester
Rochester 5134086, New York 5128638 14642
Rochester 5134086, New York 5128638 14642
Contact:
Site Public Contact
585-275-5830
Site Public Contact
585-275-5830
Sanford Bismarck Medical Center
Bismarck 5688025, North Dakota 5690763 58501
Bismarck 5688025, North Dakota 5690763 58501
Sanford Broadway Medical Center
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Sanford Roger Maris Cancer Center
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73104
ECOG-ACRIN Cancer Research Group
Philadelphia 4560349, Pennsylvania 6254927 19103
Philadelphia 4560349, Pennsylvania 6254927 19103
Sanford Cancer Center Oncology Clinic
Sioux Falls 5231851, South Dakota 5769223 57104
Sioux Falls 5231851, South Dakota 5769223 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Sioux Falls 5231851, South Dakota 5769223 57117-5134
UT Southwestern Simmons Cancer Center - RedBird
Dallas 4684888, Texas 4736286 75237
Dallas 4684888, Texas 4736286 75237
UT Southwestern/Simmons Cancer Center-Dallas
Dallas 4684888, Texas 4736286 75390
Dallas 4684888, Texas 4736286 75390
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
UT Southwestern Clinical Center at Richardson/Plano
Richardson 4722625, Texas 4736286 75080
Richardson 4722625, Texas 4736286 75080
VCU Massey Cancer Center at Stony Point
Richmond 4781708, Virginia 6254928 23235
Richmond 4781708, Virginia 6254928 23235
Virginia Commonwealth University/Massey Cancer Center
Richmond 4781708, Virginia 6254928 23298
Richmond 4781708, Virginia 6254928 23298
Marshfield Medical Center-EC Cancer Center
Eau Claire 5251436, Wisconsin 5279468 54701
Eau Claire 5251436, Wisconsin 5279468 54701
University of Wisconsin Carbone Cancer Center - University Hospital
Madison 5261457, Wisconsin 5279468 53792
Madison 5261457, Wisconsin 5279468 53792
Marshfield Clinic-Minocqua Center
Minocqua 5263156, Wisconsin 5279468 54548
Minocqua 5263156, Wisconsin 5279468 54548
Marshfield Medical Center-Rice Lake
Rice Lake 5268798, Wisconsin 5279468 54868
Rice Lake 5268798, Wisconsin 5279468 54868
Marshfield Medical Center-River Region at Stevens Point
Stevens Point 5274644, Wisconsin 5279468 54482
Stevens Point 5274644, Wisconsin 5279468 54482
Marshfield Medical Center - Weston
Weston 5278693, Wisconsin 5279468 54476
Weston 5278693, Wisconsin 5279468 54476
More Details
- NCT ID
- NCT05863351
- Status
- Recruiting
- Sponsor
- ECOG-ACRIN Cancer Research Group
Detailed Description
PRIMARY OBJECTIVES: I. To compare overall survival (OS) between patients receiving SAbR + systemic therapy (SABR+ST) versus systemic therapy (ST) only. II. To compare average adverse event (AE) score between SAbR+ST arm and ST only arm. SECONDARY OBJECTIVES: I. To compare global health status / quality of life (QOL) between patients receiving SAbR+ST 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 SAbR+ST 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 SAbR+ST 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 SabR+ST 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 SabR+ST 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 SabR+ST 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 SabR+ST versus ST alone. V. To compare time to global quality of life deterioration between patients randomized to receive SabR+ST 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.