Kidney Cancer Clinical Trial
Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study
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) 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.
Full 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.
Eligibility Criteria
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
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There are 86 Locations for this study
Birmingham Alabama, 35233, United States
Aurora Colorado, 80045, United States More Info
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Fort Collins Colorado, 80524, United States More Info
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Fort Collins Colorado, 80528, United States More Info
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Greeley Colorado, 80631, United States More Info
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Highlands Ranch Colorado, 80129, United States More Info
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Loveland Colorado, 80538, United States More Info
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Bloomington Illinois, 61701, United States More Info
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Bloomington Illinois, 61704, United States More Info
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Canton Illinois, 61520, United States More Info
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Carthage Illinois, 62321, United States More Info
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Centralia Illinois, 62801, United States More Info
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Chicago Illinois, 60611, United States More Info
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Chicago Illinois, 60612, United States More Info
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Danville Illinois, 61832, United States More Info
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Decatur Illinois, 62526, United States More Info
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Decatur Illinois, 62526, United States More Info
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DeKalb Illinois, 60115, United States More Info
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Effingham Illinois, 62401, United States More Info
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Effingham Illinois, 62401, United States More Info
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Eureka Illinois, 61530, United States More Info
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Galesburg Illinois, 61401, United States More Info
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Geneva Illinois, 60134, United States More Info
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Kewanee Illinois, 61443, United States More Info
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Macomb Illinois, 61455, United States More Info
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Mattoon Illinois, 61938, United States More Info
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O'Fallon Illinois, 62269, United States
Ottawa Illinois, 61350, United States More Info
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Pekin Illinois, 61554, United States More Info
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Peoria Illinois, 61615, United States More Info
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Peoria Illinois, 61615, United States More Info
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Peoria Illinois, 61637, United States More Info
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Peru Illinois, 61354, United States More Info
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Princeton Illinois, 61356, United States More Info
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Springfield Illinois, 62702, United States More Info
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Springfield Illinois, 62702, United States More Info
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Springfield Illinois, 62781, United States More Info
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Urbana Illinois, 61801, United States More Info
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Warrenville Illinois, 60555, United States More Info
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Washington Illinois, 61571, United States More Info
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Ames Iowa, 50010, United States More Info
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Ames Iowa, 50010, United States More Info
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Ankeny Iowa, 50023, United States More Info
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Cedar Rapids Iowa, 52403, United States More Info
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Cedar Rapids Iowa, 52403, United States More Info
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Clive Iowa, 50325, United States More Info
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Des Moines Iowa, 50309, United States More Info
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Des Moines Iowa, 50309, United States More Info
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Des Moines Iowa, 50314, United States More Info
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Fairway Kansas, 66205, United States More Info
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Kansas City Kansas, 66160, United States More Info
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Olathe Kansas, 66061, United States More Info
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Overland Park Kansas, 66210, United States More Info
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Overland Park Kansas, 66211, United States More Info
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Salina Kansas, 67401, United States More Info
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Topeka Kansas, 66606, United States More Info
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Westwood Kansas, 66205, United States More Info
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Louisville Kentucky, 40202, United States More Info
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Ann Arbor Michigan, 48106, United States More Info
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Brighton Michigan, 48114, United States More Info
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Brighton Michigan, 48114, United States More Info
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Canton Michigan, 48188, United States More Info
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Canton Michigan, 48188, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Lansing Michigan, 48912, United States More Info
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Livonia Michigan, 48154, United States More Info
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Ypsilanti Michigan, 48197, United States More Info
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Cape Girardeau Missouri, 63703, United States More Info
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Kansas City Missouri, 64154, United States More Info
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Lee's Summit Missouri, 64064, United States More Info
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North Kansas City Missouri, 64116, United States More Info
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Saint Louis Missouri, 63128, United States More Info
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Saint Louis Missouri, 63141, United States More Info
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Springfield Missouri, 65804, United States More Info
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Lake Success New York, 11042, United States More Info
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New York New York, 10021, United States More Info
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New York New York, 10065, United States More Info
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Bismarck North Dakota, 58501, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Philadelphia Pennsylvania, 19103, United States More Info
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Sioux Falls South Dakota, 57104, United States More Info
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Sioux Falls South Dakota, 57117, United States More Info
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Dallas Texas, 75237, United States More Info
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Dallas Texas, 75390, United States More Info
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Fort Worth Texas, 76104, United States More Info
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Richardson Texas, 75080, United States More Info
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Richmond Virginia, 23235, United States More Info
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Richmond Virginia, 23298, United States More Info
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Eau Claire Wisconsin, 54701, United States More Info
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Madison Wisconsin, 53792, United States More Info
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Marshfield Wisconsin, 54449, United States More Info
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Minocqua Wisconsin, 54548, United States More Info
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Rice Lake Wisconsin, 54868, United States More Info
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Stevens Point Wisconsin, 54482, United States More Info
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Weston Wisconsin, 54476, United States More Info
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