Phase III Randomized Trial of Stereotactic Ablative Radiotherapy (SAbR) for Oligometastatic Advanced Renal Carcinoma (SOAR)

Plain English Summary

Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study is a Phase 3 clinical trial sponsored by ECOG-ACRIN Cancer Research Group studying Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8. This study tests if a precise radiation technique called SAbR, given before standard treatments, is better than standard treatments alone for kidney cancer that has spread to a few other places in the body. It is for patients with advanced kidney cancer that has spread to 2-5 locations and whose primary tumor has been treated. Participation involves receiving either SAbR followed by standard systemic therapy, or just standard systemic therapy. This includes regular check-ups, imaging scans, and potentially questionnaires. Alternatives include standard systemic therapies like immunotherapy or oral medications, which are the current usual care for this type of cancer. The trial aims to enroll 472 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have a confirmed diagnosis of kidney cancer that has spread to 2-5 spots, and your primary kidney tumor has been treated. You cannot join if you have brain metastases or if the cancer has spread to certain areas like the lungs (near the airway), digestive tract, skin, or scalp. You must have a good general health status (ECOG 0-2) and your cancer should not have a specific aggressive feature (sarcomatoid component). You may have had prior treatments if you've recovered from side effects, but you cannot have received prior treatment for your metastatic kidney cancer (unless it was in the adjuvant setting). This trial is studying Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, so participants generally need a confirmed diagnosis.

What They're Measuring

Overall survival means how long patients live after starting the treatment, and the incidence of adverse events measures how often side effects occur, helping to understand the treatment's safety and The specific primary outcome measures are: Overall survival (OS) (From randomization to death from any cause, assessed up to 10 years); Incidence of adverse events (AEs) (From randomization up to 6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a gap in treatment for kidney cancer patients with limited spread, exploring if a targeted radiation approach can improve outcomes compared to current standard therapies. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, where improved treatment options are needed.

Investor Insight

This trial targets a specific subset of advanced kidney cancer, a market with significant unmet needs, potentially offering a new treatment option and indicating a competitive landscape focused on imp Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if SAbR is suitable for your specific cancer spread and if you meet all the eligibility criteria. Be prepared for regular visits for radiation, systemic therapy, imaging scans (CT, MRI), and to answer questionnaires about your quality of life. Understand that you will be randomly assigned to one of the two treatment groups. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 472 participants

Interventions

• PROCEDURE: Computed Tomography — Undergo CT
• PROCEDURE: Magnetic Resonance Imaging — Undergo MRI
• OTHER: Questionnaire Administration — Ancillary studies
• PROCEDURE: Stereotactic Ablative Radiotherapy — Undergo SAbR
• PROCEDURE: Systemic Therapy — Given standard of care systemic therapy

Primary Outcomes

• Overall survival (OS) (From randomization to death from any cause, assessed up to 10 years)
• Incidence of adverse events (AEs) (From randomization up to 6 months)

Secondary Outcomes

• Progression-free survival (PFS) (From randomization to progression of disease, assessed up to 10 years)

Full 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 adren

Trial Locations

• University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
• Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
• UCHealth University of Colorado Hospital, Aurora, Colorado, United States
• Poudre Valley Hospital, Fort Collins, Colorado, United States
• Cancer Care and Hematology-Fort Collins, Fort Collins, Colorado, United States
• UCHealth Greeley Hospital, Greeley, Colorado, United States
• UCHealth Highlands Ranch Hospital, Highlands Ranch, Colorado, United States
• Medical Center of the Rockies, Loveland, Colorado, United States
• Sibley Memorial Hospital, Washington D.C., District of Columbia, United States
• Mayo Clinic in Florida, Jacksonville, Florida, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Renal Cell Carcinoma
• Kidney Cancer
• Metastatic Cancer
• Stage IV Cancer
• Oncology
• Radiation Therapy
• Immunotherapy
• Targeted Therapy
• Solid Tumors
• Cancer Research

More Metastatic Renal Cell Carcinoma Trials

View all Metastatic Renal Cell Carcinoma clinical trials