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Trial Title:
Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer
NCT ID:
NCT02141919
Condition:
Renal Cancers
Conditions: Official terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Conditions: Keywords:
renal cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic Ablative Radiation Therapy
Description:
Stereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions
of 10Gy or 5 fractions of 8 Gy
Arm group label:
Stereotactic Ablative Radiation Therapy
Other name:
SABR
Summary:
The goal of this phase II clinical trial is to evaluate the efficacy of the completely
non-invasive treatment option of stereotactic radiation therapy for the treatment of
biopsy proven and growing small renal tumors.
Detailed description:
Current treatment options for primary renal cancer include surgery or ablative
techniques-all are invasive or minimally invasive options. The completely noninvasive
treatment option of stereotactic radiation therapy (SABR), which has become standard of
care in many cancer sites, has not been explored for primary renal cancer. With multiple
technological advances, it is now feasible to safely treat a moving intra-abdominal tumor
such as that in a kidney. This proposed clinical trial evaluates the efficacy of SABR in
treating patients with early renal cancers. Growing renal masses will first be biopsied
to confirm the diagnosis of renal cancer. Patients will then undergo treatment with SABR
of 3-5 fractions completing within three weeks. Treatment response will be evaluated
using sequential MRI scans and a second tumor biopsy one year after treatment. Monitoring
of treatment toxicity and kidney function will also be performed.
Criteria for eligibility:
Criteria:
Inclusion Criteria
- Age ≥ 18 years.
- Renal mass ≤ 5cm
- The treating renal mass must be ≤ 5cm. Other renal masses (cysts etc.) of any
size will not make the subject ineligible
- Biopsy proven Renal neoplasm
- All histology of renal cancers are included including oncocytoma
- Growth of renal mass >2mm in radiographic scans must be demonstrated within a one
year period.
- Ability to understand and the willingness to sign a written informed consent.
- Subject is able to undergo either an MRI or administration of contrast agent for CT
- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) for the duration of the
study. Should a woman become pregnant or suspect she is pregnant while participating
in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation,
having undergone a tubal ligation, or remaining celibate by choice) who meets the
following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e.,
has had menses at any time in the preceding 12 consecutive months).
Exclusion Criteria:
- Subject has received any treatment for the treating renal mass; such as RFA or
cyroablation.
- If other renal masses received RFA or cryoablation or surgery, then these
patients are eligible.
- Subjects received previous abdominal radiation
- Evidence of Metastatic Disease, unless disease-free for ≥ 3 years prior to
registration, (non-melanomatous skin cancer and in-situ cancers are okay).
- Female subjects who are pregnant or planning to become pregnant during the course of
SABR.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Texas Southwestern
Address:
City:
Dallas
Zip:
75239
Country:
United States
Start date:
June 2013
Completion date:
December 2025
Lead sponsor:
Agency:
University of Texas Southwestern Medical Center
Agency class:
Other
Source:
University of Texas Southwestern Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02141919
