Radiosurgery in Treating Patients With Kidney Tumors

Kidney Cancer Clinical Trial

Official title:

Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458484
• Other study ID #: CASE12806
• Secondary ID: P30CA043703CASE1
• Status: Completed
• Phase: N/A
• Start date: February 20, 2007
• Est. completion date: September 12, 2019

Study information

• Verified date: July 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 12, 2019
• Est. primary completion date: March 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Cancer
• Kidney Neoplasms

Intervention

Radiation:
• stereotactic radiosurgery
Series I: Radiation will be delivered in 4 fractions. Series II: Radiation will be delivered in 3 fractions.

Procedure:
• Renal Biopsy
At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
• Serum Blood Markers
ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	UH-Chagrin Highlands	Orange Village	Ohio
United States	UH-Westlake	Westlake	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose of Radiosurgery	Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.	once every 4 weeks
Secondary	Overall Survival	Radiographic efficacy as measured by overall (percent of participants still alive after study completion)	at 36 months from start of therapy
Secondary	Progression-free Survival	Percent of participants still alive and without tumor progression at study completion	at 36 months from start of therapy
Secondary	Freedom From Local Progression	Radiographic efficacy as measured as measured by freedom from local progression (percent of participants without local progression or local recurrence after study completion)	at 36 months from start of therapy
Secondary	Freedom to Distant Recurrence	Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)	at 36 months from start of therapy