Clinical trial · Interventional
Radiosurgery in Treating Patients With Kidney Tumors
Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates
NCT00458484CI-TRIAL-00046102completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Renal Biopsy | Procedure | — | UNRESOLVED |
| Serum Blood Markers | Procedure | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Series 1: Stereotactic radiosurgery
- description
- Series 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.
- interventionNames
- Radiation: stereotactic radiosurgery
- Procedure: Renal Biopsy
- Procedure: Serum Blood Markers
- type
- EXPERIMENTAL
- label
- Series 2: Stereotactic radiosurgery
- description
- Series 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.
- interventionNames
- Radiation: stereotactic radiosurgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.