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

NCT02542202 | Terminated Results FDA Device

• 3 other identifiers: IRB14-1542NCI-2015-01322P30CA014599
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Metastatic Renal Cell Cancer; Recurrent Renal Cell Carcinoma; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (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.

  Up to 1 year

Secondary Outcomes (3)

• Treated Lesion Control (LeC)

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

• Progression-free Survival

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

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

  Up to 1 year

Study Arms (1)

Stereotactic body radiation therapy

EXPERIMENTAL

Patients 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.

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

Undergo stereotactic body radiation therapy

Also known as: SBRT

Stereotactic body radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Rohan Katipally
• Organization: UChicago

Rohan.Katipally@bsd.uchicago.edu

773-702-0137

Study Officials

• Stanley Liauw

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 4, 2015
• Study Start: May 1, 2015
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Locations

US (1)