Radiosurgery in Treating Patients With Kidney Tumors

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00458484

Enrollment

Registered

2007-04-11

Start date

2007-02-20

Completion date

2019-09-12

Last updated

2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

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

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.

Interventions

RADIATIONstereotactic radiosurgery

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

PROCEDURERenal Biopsy

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

PROCEDURESerum 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Overall Survival	at 36 months from start of therapy	Radiographic efficacy as measured by overall (percent of participants still alive after study completion)
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)

Countries

United States

Participant flow

Recruitment details

Participants were recruited local hospital from 2/2007 to 5/2017.

Participants by arm

Arm	Count
Series 1/Dose Level 1: Stereotactic Radiosurgery Series I: Radiation will be delivered in 4 fractions: 6 Gy x 4 fractions total dose of 24 Gy. 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.	4
Series 1/Dose Level 2: Stereotactic Radiosurgery Series I: Radiation will be delivered in 4 fractions: 8 Gy x 4 fractions total dose of 32 Gy. 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.	6
Series 1/Dose Level 3: Stereotactic Radiosurgery Series I: Radiation will be delivered in 4 fractions: 10 Gy x 4 fractions total dose of 40 Gy. 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.	3
Series 1/Dose Level 4: Stereotactic Radiosurgery Series I: Radiation will be delivered in 4 fractions: 12 Gy x 4 fractions total dose of 48 Gy. 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.	6
Series 2/Dose Level 1: Stereotactic Radiosurgery Series II: Radiation will be delivered in 3 fractions: 16 Gy x 3 fractions total dose of 48 Gy. 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.	4
Series 2/Dose Level 2: Stereotactic Radiosurgery Series II: Radiation will be delivered in 3 fractions: 18 Gy x 3 fractions total dose of 54 Gy. 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.	4
Series 2/Dose Level 3: Stereotactic Radiosurgery Series II: Radiation will be delivered in 3 fractions: 20 Gy x 3 fractions total dose of 60 Gy. 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.	3
Total	30

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006
Overall Study	Not eligible b/c prior radiation history	0	0	0	0	0	1	0

Baseline characteristics

Characteristic	Total	Series 1/Dose Level 2: Stereotactic Radiosurgery	Series 1/Dose Level 3: Stereotactic Radiosurgery	Series 1/Dose Level 4: Stereotactic Radiosurgery	Series 2/Dose Level 1: Stereotactic Radiosurgery	Series 1/Dose Level 1: Stereotactic Radiosurgery	Series 2/Dose Level 2: Stereotactic Radiosurgery	Series 2/Dose Level 3: Stereotactic Radiosurgery
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	26 Participants	6 Participants	3 Participants	5 Participants	3 Participants	4 Participants	3 Participants	2 Participants
Age, Categorical Between 18 and 65 years	4 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants	6 Participants	3 Participants	5 Participants	4 Participants	4 Participants	4 Participants	3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	4 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	26 Participants	6 Participants	2 Participants	5 Participants	4 Participants	3 Participants	3 Participants	3 Participants
Region of Enrollment United States	30 participants	6 participants	3 participants	6 participants	4 participants	4 participants	4 participants	3 participants
Sex: Female, Male Female	8 Participants	3 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Sex: Female, Male Male	22 Participants	3 Participants	2 Participants	5 Participants	4 Participants	3 Participants	3 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	1 / 4	0 / 6	1 / 3	2 / 6	1 / 4	0 / 4	0 / 3
other Total, other adverse events	0 / 4	1 / 6	0 / 3	1 / 6	1 / 4	3 / 4	2 / 3
serious Total, serious adverse events	2 / 4	1 / 6	1 / 3	3 / 6	3 / 4	1 / 4	1 / 3

Outcome results

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.

Time frame: once every 4 weeks