Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer

• ClinicalTrials.gov Identifier: NCT02141919
• Recruitment Status: Active, not recruiting
• First Posted: May 20, 2014
• Last Update Posted: October 22, 2021
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Raquibul Hannan, University of Texas Southwestern Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Renal Cancers	Radiation: Stereotactic Ablative Radiation Therapy	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Primary Renal Cancer (RCC)
• Actual Study Start Date: June 2013
• Estimated Primary Completion Date: November 2024
• Estimated Study Completion Date: December 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Stereotactic Ablative Radiation Therapy; Stereotactic Ablative Radiation Therapy (SABR)	Radiation: Stereotactic Ablative Radiation Therapy; Stereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions of 10Gy or 5 fractions of 8 Gy; Other Name: SABR

Outcome Measures

Primary Outcome Measures :

1. Eliminate its growth and tumor viability. [ Time Frame: 2 years ]
   To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor.

Secondary Outcome Measures :

1. Adverse events [ Time Frame: 2 years ]
   To describe the adverse events associated with the administration of SABR to renal tumors.
2. growth rate of renal tumors [ Time Frame: 2 years ]
   To measure the growth rate of renal tumors after SABR treatment.
3. Renal function [ Time Frame: 2 years ]
   To measure the changes in kidney function, creatinine levels, renal perfusion and GFR after SABR treatment
4. Tumor Viability [ Time Frame: one year ]
   To measure tumor viability pathologically one year after SABR treatment with biopsy.
5. progression of disease [ Time Frame: 2 years ]

   To assess radiographic changes to the renal tumor after SABR treatment including tumor viability, enhancement necrosis,T2 tumor cellularity with diffusion-weighted imaging. To assess local, regional and systemic progression of disease after SABR to SRM .To assess time to progression (TTP) of disease from the first SABR treatment.

   To assess progression free survival (PFS). PFS is defined as the length of time from start of treatment to the time of loco-regional disease progression or death from any cause.

   To assess overall survival (OS). OS is defined as the duration of time from start of treatment to the time of death from any cause.

   To assess tumor growth, local failure and indeterminate disease response (IDR).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Texas

University of Texas Southwestern

Dallas, Texas, United States, 75239

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Raquibul Hannan, MD, PhD; UTSW

  Study Documents (Full-Text)

Documents provided by Raquibul Hannan, University of Texas Southwestern Medical Center:

Study Protocol  [PDF] May 19, 2020

More Information

• Responsible Party: Raquibul Hannan, Associate Professor of Medicine, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02141919
• Other Study ID Numbers: STU 122013-030
• First Posted: May 20, 2014
• Last Update Posted: October 22, 2021
• Last Verified: October 2021

Keywords provided by Raquibul Hannan, University of Texas Southwestern Medical Center:

renal cancer

Additional relevant MeSH terms:

Kidney Neoplasms; Carcinoma, Renal Cell; Kidney Diseases; Carcinoma; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type