Radiosurgery in Treating Patients With Kidney Tumors

Not Applicable

Completed

• Conditions: Kidney Cancer
• Interventions: Radiation: stereotactic radiosurgery; Procedure: Renal Biopsy; Procedure: Serum Blood Markers

• Registration Number: NCT00458484
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2007-02-20
• Study First Submitted: 2007-04-09
• Study First Submitted QC: 2007-04-09
• Study First Posted: 2007-04-11
• Primary Completion: 2017-03-12
• Study Completion: 2019-09-12
• Results First Submitted: 2020-04-08
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Results First Posted: 2020-07-22
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Series 2: Stereotactic radiosurgery	stereotactic radiosurgery	Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
Series 2: Stereotactic radiosurgery	Serum Blood Markers	Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.
Series 1: Stereotactic radiosurgery	stereotactic radiosurgery	Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
Series 1: Stereotactic radiosurgery	Serum Blood Markers	Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
Series 1: Stereotactic radiosurgery	Renal Biopsy	Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
Series 2: Stereotactic radiosurgery	Renal Biopsy	Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose of Radiosurgery	once every 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	at 36 months from start of therapy	Percent of participants still alive and without tumor progression at study completion
Freedom From Local Progression	at 36 months from start of therapy	Radiographic efficacy as measured as measured by freedom from local progression (percent of participants without local progression or local recurrence after study completion)
Freedom to Distant Recurrence	at 36 months from start of therapy	Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)
Overall Survival	at 36 months from start of therapy	Radiographic efficacy as measured by overall (percent of participants still alive after study completion)

Trial Locations

Locations (3)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

UH-Westlake; 🇺🇸 Westlake, Ohio, United States

UH-Chagrin Highlands; 🇺🇸 Orange Village, Ohio, United States