Safety and Preliminary Efficacy of SBRT in Patients With Metastatic RCC Treated With Targeted or IO Therapy

NCT02864615 | Completed

• 1 other identifier: KCRB29022016
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this phase 1b study is to evaluate safety and preliminary efficacy of stereotactic body radiation therapy in patients with metastatic renal cell carcinoma treated with VEGFR, mTOR or immune checkpoint inhibitors.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

renal cell carcinoma; metastasis; stereotactic body radiation therapy; targted therapy; immune checkpoint inhibitors

Outcome Measures

Primary Outcomes (1)

• Rate of adverse events of SBRT

  4 months

Secondary Outcomes (2)

• Rate of reduction in size of first metastasis exposed to radiation

  4 months

• Time to progression of first (study) and second (control) metastases

  8 months

Study Arms (1)

Stereotactic Body Radiation Therapy

EXPERIMENTAL

Patients with stable disease on targeted or IO therapy will receive SBRT on first metastasis of clear cell renal cell carcinoma. Second metastasis will be as a control. In case of safety and 50% reduction in size of first metastasis, up to 10 metastasis will be treated with SBRT.

Radiation: SBRT

Interventions

SBRT RADIATION

Dose and schedule will be depended on metastases location.

Stereotactic Body Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clear cell renal cell carcinoma
• confirmed distant metastases
• previous nephrectomy
• stable disease or durable partial response on recommended targeted and IO therapy
• age: \> 18 years
• signed informed consent

You may not qualify if:

• unability to select first and second metastases
• history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
• other malignancy
• grade 3 and 4 toxicity of targeted therapy

Sponsors & Collaborators

• Kidney Cancer Research Bureau: lead

Study Sites (1)

Ulyanovsk regional cancer center

Ulyanovsk, Ulyanovsk Oblast, Russia

Location

Related Publications (1)

• Dengina N, Mitin T, Gamayunov S, Safina S, Kreinina Y, Tsimafeyeu I. Stereotactic body radiation therapy in combination with systemic therapy for metastatic renal cell carcinoma: a prospective multicentre study. ESMO Open. 2019 Oct 13;4(5):e000535. doi: 10.1136/esmoopen-2019-000535. eCollection 2019.

  PMID: 31673426 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ilya Tsimafeyeu, M.D.

  Kidney Cancer Research Bureau

  STUDY DIRECTOR

• Natalia Dengina, M.D.

  Ulyanovsk Regional Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 22, 2019

Record last verified: 2019-10

Locations

RU (1)