N/A
N=31
Radiosurgery in Treating Patients With Kidney Tumors
Kidney Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00458484 ↗Enrolled (actual)
31
Serious AEs
40.0%
Results posted
Jul 2020
Primary outcome: Primary: Maximum Tolerated Dose of Radiosurgery — 48; 60 Gy
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- stereotactic radiosurgery (Radiation); Renal Biopsy (Procedure); Serum Blood Markers (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of Radiosurgery |
48; 60 | — |
| SECONDARY Overall Survival |
75; 100; 33; 66; 66; 100 | — |
| SECONDARY Progression-free Survival |
75; 100; 33; 66; 33; 100 | — |
| SECONDARY Freedom From Local Progression |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Freedom to Distant Recurrence |
100; 100; 100; 100; 75; 100 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00458484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.