Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Withdrawn; Phase 1

Conditions: Kidney Cancer

Treatments: Procedure: conventional surgery; Radiation: stereotactic radiosurgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00445757

P30CA043703 (U.S. NIH Grant/Contract)

CASE5806 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)