SAbR With Oligo-Progressive Renal Cell Cancer.

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

October 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to change of systemic therapy[ Time Frame: 2 Years ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Progression-free survival (PFS)[ Time Frame: 6 years ]
Progression-Free Survival on systemic therapy started (PFS-ST) after progression on SAbR with existing or new progression at >3 or >30% of all lesions.
Acute & Delayed Toxicity[ Time Frame: 6 Years ]
Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. The consequences of toxicity should all be graded 1-5 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Local Control[ Time Frame: 6 Years ]
Radiographic progression with >20% increase in the longest diameter of the treated lesions.
Health-related quality of life (HRQOL)[ Time Frame: 6 Years ]
HRQOL will be measured using FACT-G.
Health-related quality of life (HRQOL)[ Time Frame: 6 years ]
HRQOL will be measured using EQ-5D-5L.
Quality of life (QOL)[ Time Frame: 6 years ]
HRQOL will be measured using FKSI.
Quality of life with cost involved[ Time Frame: 6 years ]
QOL will be measured using Cost & Convenience Questionnaire.

Descriptive Information

Brief Title ^ICMJE

SAbR With Oligo-Progressive Renal Cell Cancer.

Official Title ^ICMJE

A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cancer (RCC).

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. 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. 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: - To measure the toxicity, safety and tolerance. - To evaluate the progression free survival (PFS) on subsequent systemic therapy after progression on SAbR. - To measure the impact on health-related quality of life (HRQOL). - To evaluate local control of SAbR for RCC Sample Size: 20 Patients Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Radiation: Stereotactic ablative body radiation (SABR)
SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.

Study Arms

Experimental: Stereotactic ablative body radiation (SABR)
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.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 1, 2024

Estimated Primary Completion Date

October 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Metastatic renal cell carcinoma with systemic therapy (oligo-progression defined as ≤3 sites of metastasis). - Radio-graphic evidence of metastatic disease. Exclusion Criteria: - Subjects with ≥3 unfavorable prognostic factors defined by IMDC. - Subjects with history of or new brain metastasis.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Texas Southwestern Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Raquibul Hannan, MD, PhD University of Texas

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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