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Metastatic Renal Cell CancerNCT02542202

Stereotactic Body Radiation Therapy in Treating Patients With Metastatic or Recurrent Kidney Cancer

A study testing Stereotactic Body Radiation Therapy in people with Metastatic Renal Cell Cancer and Recurrent Renal Cell Carcinoma, run by University of Chicago at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This pilot clinical trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with kidney cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stereotactic Body Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
1 May 2015to 23 Mar 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed metastatic or recurrent RCC (any histologic subtype)
  • Patients must have between 1 to 5 new or recurrent lesions suspicious for metastatic RCC on diagnostic imaging
  • Each extracranial lesion must be =< 6 cm and amenable to SBRT or surgical excision
  • Patients must have 3 or fewer brain metastases, of size =< 4 cm
  • Brain metastases must be treated prior to enrollment in the study; the modality of treatment of brain metastases can include surgical resection, whole brain radiotherapy, stereotactic radiosurgery, or any combination of the above
  • Patients who have an intact unresected primary tumor should be considered for radical nephrectomy and primary resection prior to enrollment in the study; if the patient is not eligible for surgical resection, the primary tumor must be amenable to SBRT or request for applications (RFA); generally, this will be defined as a primary tumor < 10 cm in size or a primary lesion which can be treated to a dose of >= 8 Gy x 5 without excessive perceived risk of toxicity
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  • Patients must have had at least a computed tomography (CT) of the chest, abdomen, and pelvis within 4 weeks of registration in the trial; CT or magnetic resonance imaging (MRI) of the brain is only required in the presence of neurologic symptoms
  • Patients must have had no radiotherapy, immunotherapy, chemotherapy or therapy with targeted agents within the last 1 month
  • Patients may not have had prior bevacizumab, based on case reports of tracheoesophageal fistula in patients treated with bevacizumab and radiotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status =<2
  • Age 18 years or older
  • Life expectancy of >= 3 months
  • Patients must have normal organ and marrow function within 30 days of registration, as defined below:
  • Absolute neutrophil count >= 500/mcL
  • Hemoglobin >= 8.0 g/dL
  • Platelets >= 50,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal if liver metastases are present
  • Women of childbearing potential must have a negative pregnancy test within 14 days of registration
  • Patients must have the ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients who have had prior chemotherapy, immunotherapy, targeted therapy, or radiotherapy within 1 month of enrollment
  • Patients who have had any prior bevacizumab, due to case reports suggesting a possible risk of severe toxicity in combination with radiotherapy
  • Patients with radiographic or clinical findings of spinal cord compression or cauda equina syndrome with neurologic deficit thought to be due to malignancy
  • Patients may not be receiving any systemic anti-cancer agents or other investigational agents during radiation therapy
  • Patients may not have received prior radiation therapy to a site of recurrence which would require overlap of appreciable radiation dose
  • Known active invasive malignancy except for renal cell carcinoma and/or non-melanoma skin cancer
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  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration;
  • Transmural myocardial infarction within the last 6 months prior to registration;
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration;
  • Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease if the liver is involved with metastatic disease;
  • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
  • Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: A Pilot Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Renal Cell Carcinoma

This pilot clinical trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with kidney cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.

Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02542202
Study groupRoleWhat they receive
Stereotactic body radiation therapyExperimentalPatients undergo stereotactic body radiation therapy on day 1 over 3 times a week for 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity

    RT-related grade >= 4 toxicity will be determined on a case-by-case basis by the study group, taking into consideration the region treated with SBRT, timing of the toxicity, and the nature of the toxicity. Rates of RT-related grade >= 4 toxicity will be recorded, time to RT-related grade >= 4 toxicity will be recorded, and freedom from RT-related grade >= 4 toxicity will be determined using the Kaplan-Meier method.

    Measured: Up to 1 year

Secondary outcomes (3)

  1. Treated Lesion Control (LeC)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: From the start of treatment to the time of local progression at each treated lesion, assessed up to 1 year

  2. Progression-free Survival

    Progression-free survival is defined as defined as progression in the treated lesion, organ in which the treated lesion is present, distant failure, or death from any cause any new sites of disease on imaging or any progressive disease by RECIST criteria at initially treated sites of disease (within 80% isodose line). PFS will be estimated using descriptive statistics and the Kaplan-Meier method.

    Measured: From start of treatment to time of progression, assessed up to 1 year

  3. Toxicity Profile of 5-fraction SBRT Based on Normal Tissue Dosimetric Constraints Based on the Organ Site of Involvement

    Toxicities of interest that occur within the 3-12 month time frame after RT start will be documented and analyzed using descriptive statistics and the Kaplan-Meier method.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2015 (estimated)
  2. Study start1 May 2015
  3. Primary completion23 Mar 2023
  4. Study completion23 Mar 2023

Why it stopped: due to slow enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02542202
Sponsor's protocol ID
IRB14-1542
Other IDs
NCI-2015-01322, IRB14-1542, P30CA014599
Status last verified
May 2024
First submitted
27 Aug 2015
Last updated
30 May 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Katipally RR, Rajeev-Kumar G, Solanki AA, Arif F, Eggener SE, Sidana A, Szmulewitz RZ, Stadler WM, Sweis RF, Pitroda SP, Liauw SL. A Prospective Study of Stereotactic Body Radiation Therapy in Oligometastatic Renal Cell Carcinoma. Int J Radiat Oncol Biol Phys. 2026 May 1;125(1):164-170. doi: 10.1016/j.ijrobp.2025.05.059. Epub 2025 May 30.

    PubMed 40451439

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Body Radiation Therapy in people with Metastatic Renal Cell Cancer and Recurrent Renal Cell Carcinoma, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Radiation Therapy (RT)-Related Grade >= 4 Toxicity (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02542202, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.

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