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Radiosurgery in Treating Patients With Kidney Tumors

Primary Purpose

Kidney Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

stereotactic radiosurgery

Renal Biopsy

Serum Blood Markers

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
UH-Chagrin Highlands
UH-Westlake

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Series 1: Stereotactic radiosurgery

Series 2: Stereotactic radiosurgery

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival

Radiographic efficacy as measured by overall (percent of participants still alive after study completion)

Progression-free Survival

Percent of participants still alive and without tumor progression at study completion

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)

Freedom to Distant Recurrence

Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)

Full Information

NCT ID

NCT00458484

First Posted

April 9, 2007

Last Updated

July 7, 2020

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00458484

Brief Title

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

February 20, 2007 (Actual)

Primary Completion Date

March 12, 2017 (Actual)

Study Completion Date

September 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Series 1: Stereotactic radiosurgery

Arm Type

Experimental

Arm Description

Arm Title

Series 2: Stereotactic radiosurgery

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

stereotactic radiosurgery

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Renal Biopsy

Intervention Description

At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Intervention Type

Procedure

Intervention Name(s)

Serum Blood Markers

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose of Radiosurgery

Description

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.

Time Frame

once every 4 weeks

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Radiographic efficacy as measured by overall (percent of participants still alive after study completion)

Time Frame

at 36 months from start of therapy

Title

Progression-free Survival

Description

Percent of participants still alive and without tumor progression at study completion

Time Frame

at 36 months from start of therapy

Title

Freedom From Local Progression

Description

Radiographic efficacy as measured as measured by freedom from local progression (percent of participants without local progression or local recurrence after study completion)

Time Frame

at 36 months from start of therapy

Title

Freedom to Distant Recurrence

Description

Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)

Time Frame

at 36 months from start of therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitchell Machtay, MD

Organizational Affiliation

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-5065

Country

United States

Facility Name

UH-Chagrin Highlands

City

Orange Village

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

UH-Westlake

City

Westlake

State/Province

Ohio

ZIP/Postal Code

44145

Country

United States

12. IPD Sharing Statement

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Radiosurgery in Treating Patients With Kidney Tumors

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