Radiosurgery in Treating Patients With Kidney Tumors
Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates
3 other identifiers
interventional
31
1 country
3
Brief Summary
RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2007
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2007
CompletedFirst Submitted
Initial submission to the registry
April 9, 2007
CompletedFirst Posted
Study publicly available on registry
April 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2019
CompletedResults Posted
Study results publicly available
July 22, 2020
CompletedJuly 22, 2020
July 1, 2020
10.1 years
April 9, 2007
April 8, 2020
July 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose of Radiosurgery
Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.
once every 4 weeks
Secondary Outcomes (4)
Overall Survival
at 36 months from start of therapy
Progression-free Survival
at 36 months from start of therapy
Freedom From Local Progression
at 36 months from start of therapy
Freedom to Distant Recurrence
at 36 months from start of therapy
Study Arms (2)
Series 1: Stereotactic radiosurgery
EXPERIMENTALSeries I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
Series 2: Stereotactic radiosurgery
EXPERIMENTALSeries II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
Interventions
Series I: Radiation will be delivered in 4 fractions. Series II: Radiation will be delivered in 3 fractions.
At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
Eligibility Criteria
You may qualify if:
- Patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (No major psychiatric illnesses.)
- Patient is able to give and sign study specific informed consent
- No prior radiation to the treatment field
- Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
- Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor
- Karnofsky status of ≥ 60%
- Signed study-specific informed consent prior to study entry
You may not qualify if:
- Any patient not meeting the eligibility criteria.
- Any patient with active connective tissue disease such as lupus, dermatomyositis.
- Any patient with active Crohn's disease or active ulcerative colitis.
- Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Comprehensive Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
UH-Chagrin Highlands
Orange, Ohio, 44122, United States
UH-Westlake
Westlake, Ohio, 44145, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mitchell Machtay MD
- Organization
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell Machtay, MD
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2007
First Posted
April 11, 2007
Study Start
February 20, 2007
Primary Completion
March 12, 2017
Study Completion
September 12, 2019
Last Updated
July 22, 2020
Results First Posted
July 22, 2020
Record last verified: 2020-07