Clinical trial NCT03696277: SAbR For Oligo-Progressive Renal Cell Cancer.
Official title: A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cell Cancer (RCC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oligoprogressive Renal Cell Carcinoma
Keywords: Stereotactic, Radiotherapy,
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The study is a prospective phase II, single arm, open label trial evaluating Stereotactic Ablative Radiation Therapy (SAbR) for patients with oligo-progressive RCC (Renal Cell Cancer).

Problem Statements:

* Can local therapy (SAbR) for oligoprogression delay the change of systemic therapy if progression is minimal to the progressive sites?
* Safely delaying the change of systemic therapy can have significant quality of life benefits for patients with oligo-progressive RCC.
* Can SAbR potentially improve progression free survival in oligoprogressive RCC patients?

Primary Endpoint:

• Time to change of systemic therapy.

Secondary Endpoint:

* PFS on subsequent systemic therapy (PFS-SST) after progression on SAbR.
* Overall survival(OS).
* Toxicity, safety and tolerance.
* Impact on health-related quality of life (HRQoL).

Sample Size: 20 Patients

Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.

Eligibility criteria: Inclusion Criteria:

1. Pathology proven renal cell carcinoma and radiographic confirmation of metastatic renal cell carcinoma
2. Patients must have drug responsive RCC as determined by treating medical or radiation oncologist after at least one set of scans.
3. 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).
4. Must be at least 18 years old
5. ECOG 0-2; or KPS \> 60
6. 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.
7. Ability to understand and the willingness to sign a written informed consent.
8. Acceptable tolerability of ongoing therapy as decided by the treating medical oncologist
9. Patient must have a desire to continue ongoing therapy
10. 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

Exclusion Criteria:

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

Primary outcomes:
measure: Time to change of systemic therapy
timeFrame: 2 Years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 6 years
measure: Overall survival
timeFrame: 6 Years
measure: Number of participants with adverse events
timeFrame: 6 Years
measure: Health-related quality of life (HRQOL)
timeFrame: 6 Years
measure: Health-related quality of life (HRQOL)
timeFrame: 6 years
measure: Quality of life (QOL)
timeFrame: 6 years
measure: Quality of life with cost involved
timeFrame: 6 years
measure: Local control
timeFrame: 6 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas
name: Raquibul Hannan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: