Systemic Therapy Alone or With Stereotactic Body Radiotherapy for Oligometastatic Kidney Cancer (STROKER Study)

NCT06726421 | Recruiting Phase 3

• 2 other identifiers: 2024-FXY-190B2024-536-01
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 9

Brief Summary

This phase III randomized controlled trial evaluates the efficacy of stereotactic body radiation therapy (SBRT) in oligometastatic renal cell carcinoma. The study aims to determine if the addition of SBRT to standard systemic therapy prolong survival compared to the standard systemic therapy alone. In addition, the study will explore the impact of this combined modality therapy on patients' toxicity and quality of life. The researchers will compare SBRT plus standard systemic therapy to standard systemic therapy alone, which is targeted agents and immunotherapy in this case, to determine if SBRT could prolong survival.

Conditions

Renal Cell Carcinoma (Kidney Cancer); Kidney Cancer Metastatic; Renal Cell Carcinoma Metastatic

Keywords

radiotherapy; SBRT; SABR; oligometastatic; oligometastasis

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  the time from randomization to the first occurrence of tumor progression or death. If no progression occurs, PFS is measured up to the date of the last follow-up.

  From enrollment to disease progression, up to 5 years

Secondary Outcomes (9)

• Overall survival

  From enrollment to death from any cause, up to 5 years

• Cancer specific survival

  From enrollment to death from cancer, up to 5 years

• Local control rate

  From enrollment to in-field progression, up to 5 years

• Post-treatment progression free survival

  From the initiation of systemic treatment to disease progression, up to 5 years

• Progression-free survival 2

  From the initiation of systemic treatment to disease progression, up to 5 years

Study Arms (2)

SBRT arm

EXPERIMENTAL

Patients undergo SBRT to all metastatic sites in addition to standard systemic therapy. Patients should complete radiotherapy for all lesions within 6 months of enrollment, preferably within the first 3 months.

Radiation: Stereotactic body radiotherapy (SBRT); Drug: axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib

Control arm

ACTIVE COMPARATOR

Patients receive standard systemic therapy.

Drug: axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib

Interventions

Stereotactic body radiotherapy (SBRT) RADIATION

The preferred treatment plan is SBRT with a fraction dose ≥7 Gy. The prescription dose should ensure a BED of no less than 115. Radiotherapy is usually delivered daily, every other day, or other interval decided by treating radiation oncologist.

Also known as: Stereotactic ablative radiotherapy

SBRT arm

axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib DRUG

Standard systemic therapy are targeted agents or their combination with immunotherapy recommended by guidelines. This may include axitinib ± immune checkpoint inhibitors (ICIs), lenvatinib ± ICIs, cabozantinib ± ICIs, sunitinib and pazopanib, etc.

Also known as: Standard systemic therapy

Control arm; SBRT arm

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed diagnosis of renal cell carcinoma of any histology
• Age ≥ 18 years.
• ECOG performance status of 0-2.
• Imaging suggests the presence of distant metastases, with no more than 5 metastatic lesions according to RECIST 1.1 criteria and MDA standards.
• The patient has received local therapy to primary site, including surgery, stereotactic radiotherapy, or ablation.
• The patient has received no more than 2 lines of systemic therapy.
• No significant impairment of major organ function:
• Hemoglobin (HB) ≥ 80 g/L Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelets (PLT) ≥ 75 × 10⁹/L Serum total bilirubin ≤ 1.5 × ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN

You may not qualify if:

• Presence of intracranial metastases.
• Target lesions have previously received high-dose irradiation with .
• Target lesions are unsuitable for radiation therapy judged by treating radiation oncologist (e.g., lesions invading the gastrointestinal tract or penetrating the bronchus).
• Uncontrollable metastatic pleural effusion or ascites.
• Presence of other malignancies that have not been cured.
• History of significant psychiatric disorders that impede understanding of informed consent and compliance with the study protocol.
• Presence of other serious illnesses that may pose significant risks or affect radiation therapy.
• Women who are pregnant, breastfeeding, or with plans for childbearing during the study.
• Any other reasons deemed by the investigator to make the subject unsuitable for participation in the study.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (9)

Union Hospital, Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, 100034, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Radiosurgery; Sunitinib; pazopanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; 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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Liru He, PhD

CONTACT

0086-13631365597; helir@wy.sysucc.org.cn

Fangjian Zhou, PhD

CONTACT

0086-13922735659; zhoufj@wy.sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 10, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2033
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)