Clinical trial NCT00445757: Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors
Official title: Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Kidney Cancer
Keywords: stage I renal cell cancer
stage II renal cell cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Maximum tolerated dose of radiation
timeFrame: DLT is assessed at 4 and 8 weeks after radiotherapy
measure: Radiotherapy-associated toxicity
timeFrame: DLT is assessed at 4 and 8 weeks after radiotherapy
Secondary outcomes:
measure: Disease-free survival
timeFrame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
measure: Time to local progression
timeFrame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
measure: Time to distant failure
timeFrame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
measure: Survival
timeFrame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
measure: Disease-specific survival
timeFrame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Lee E. Ponsky, MD
role: PRINCIPAL_INVESTIGATOR
References: