SAbR For Oligo-Progressive Renal Cell Cancer.

NCT03696277 | Completed Phase 2 DMC

• 1 other identifier: STU 052018-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Metastatic kidney cancer patients on systemic therapy often develop resistance to limited sites that leads to changing of the systemic therapy. Local therapy to the sites of progression may allow patients to continue on the same systemic therapy that is otherwise effective and being tolerated well. Hypothesis: Stereotactic ablative radiation (SAbR) can delay the change of systemic therapy with oligoprogressive renal cell cancer (RCC) and improve progression free survival (PFS). Primary Objectives:

• To evaluate the benefit of SAbR for oligo-progressive mRCC (Metastatic Renal Cell Cancer). Secondary Objectives:
• To measure the toxicity, safety and tolerance of concurrent systemic therapy and SAbR for mRCC patients and its impact on quality of life.

Conditions

Oligoprogressive Renal Cell Carcinoma

Keywords

Stereotactic, Radiotherapy,

Outcome Measures

Primary Outcomes (1)

• Time to change of systemic therapy

  SAbR for oligo-progression will be measured to delay the change of systemic therapy.

  2 Years

Secondary Outcomes (8)

• Progression-free survival (PFS)

  6 years

• Overall survival

  6 Years

• Number of participants with adverse events

  6 Years

• Health-related quality of life (HRQOL)

  6 Years

• Health-related quality of life (HRQOL)

  6 years

Study Arms (1)

Stereotactic ablative body radiation (SABR)

EXPERIMENTAL

SAbR will be used to treat all sites of measurable metastases. New sites of metastasis will be treated if deemed appropriate by both medical and radiation oncologists with SAbR.

Radiation: Stereotactic ablative body radiation (SABR)

Interventions

Stereotactic ablative body radiation (SABR) RADIATION

SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.

Stereotactic ablative body radiation (SABR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathology proven renal cell carcinoma and radiographic confirmation of metastatic renal cell carcinoma
• Patients must have drug responsive RCC as determined by treating medical or radiation oncologist after at least one set of scans.
• Must be on systemic therapy with radiographic scans to verify olio-progression of ≤3 sites and ≤ 30% of all sites.
• Any FDA approved systemic therapy for RCC is allowed. Currently these include small molecule tyrosine kinase inhibitors (TKIs) targeting the vascular endothelial growth factor (VEGF) pathway (sunitinib, pazopanib, cabozantinib, axitinib, sorafenib), monoclonal antibody targeting the same pathway (bevacizumab), the mammalian target of rapamycin pathway (temsirolimus, everolimus), Immune checkpoint inhibitors (Nivolumab and Nivolumab concurrent with Ipilimumab, Lenvatinib in combination with everolimus and nivolumab).
• Must be at least 18 years old
• ECOG 0-2; or KPS \> 60
• Currently receiving 1st - 4th line of systemic therapy
• Any of the above listed systemic therapy is allowed as long as they are being used in the 1st-4th line setting.
• Ability to understand and the willingness to sign a written informed consent.
• Acceptable tolerability of ongoing therapy as decided by the treating medical oncologist
• Patient must have a desire to continue ongoing therapy
• All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. 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, marital status, 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

You may not qualify if:

• Subjects with ≥3 unfavorable prognostic factors defined by IMDC (International Metastatic Renal Cell Carcinoma).
• Subjects with history of or new brain metastasis.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Study Officials

• Raquibul Hannan, MD, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 4, 2018
• Study Start: October 1, 2018
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

US (1)