Kidney Cancer
Conditions
Keywords
stage I renal cell cancer, stage II renal cell cancer
Brief summary
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with kidney tumors.
Detailed description
OBJECTIVES: Primary * Determine the maximum tolerated dose of radiation in patients undergoing stereotactic radiotherapy for renal tumors. * Determine radiotherapy-associated toxicity in these patients. Secondary * Determine preoperative pathologic response to this regimen in these patients. OUTLINE: This is a dose-escalation study of radiotherapy. * Radiotherapy: Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (MTD) or upper limit is reached. The MTD is defined as the dose preceding that at which at least 2 of 4 or 3 of 8 patients experience dose-limiting toxicity (DLT). DLT is assessed at 4 and 8 weeks after radiotherapy. * Surgery: Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy. After completion of study therapy, patients are followed periodically for at least 2 years. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Interventions
PROCEDUREconventional surgery
Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.
RADIATIONstereotactic radiosurgery
Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (MTD) or upper limit is reached.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Radiologically confirmed renal tumor * At least 4 cm in greatest dimension * No clinically, radiologically, or pathologically involved lymph nodes * No distant metastases PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Negative pregnancy test * Fertile patients must use effective contraception * Medically eligible for tumor resection * No major medical condition or psychiatric illness that would preclude study compliance * No active connective tissue disease, such as lupus or dermatomyositis * No active Crohn's disease or active ulcerative colitis PRIOR CONCURRENT THERAPY: * No prior chemotherapy * No prior abdominal or pelvic radiotherapy * No prior cryosurgery * No prior radiofrequency ablation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose of radiation | DLT is assessed at 4 and 8 weeks after radiotherapy |
| Radiotherapy-associated toxicity | DLT is assessed at 4 and 8 weeks after radiotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Time to distant failure | follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery |
| Disease-free survival | follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery |
| Disease-specific survival | follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery |
| Survival | follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery |
| Time to local progression | follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery |
Countries
United States
Outcome results
None listed