Clinical trial NCT00458484: Radiosurgery in Treating Patients With Kidney Tumors
Official title: Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Cancer
Keywords: stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-04-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: OBJECTIVES:

Primary

* To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.

Secondary

* To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.

Serum Blood Marker Objective:

* To determine if serum markers collected before and after radiation may give a predictive indication of tumor response.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.

After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

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.

Primary outcomes:
measure: Maximum Tolerated Dose of Radiosurgery
timeFrame: once every 4 weeks
Secondary outcomes:
measure: Overall Survival
timeFrame: at 36 months from start of therapy
measure: Progression-free Survival
timeFrame: at 36 months from start of therapy
measure: Freedom From Local Progression
timeFrame: at 36 months from start of therapy
measure: Freedom to Distant Recurrence
timeFrame: at 36 months from start of therapy
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Orange Village
country: United States
facility: UH-Chagrin Highlands
state: Ohio
city: Westlake
country: United States
facility: UH-Westlake
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
name: Mitchell Machtay, MD
role: PRINCIPAL_INVESTIGATOR
References: