A Prospective Registry Study of Stereotactic Ablative Radiotherapy (SABR) for Oligometastatic/Oligometastatic Renal Cell Carcinoma

NCT06585878 | Not Yet Recruiting

• 1 other identifier: NCC4712
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study the efficacy and toxicity of SABR treatment for oligometastatic/oligoprogressive renal cell carcinoma; investigate the effectiveness and safety of SABR combined with targeted immunotherapy; conduct stratified analysis to identify the optimal beneficiary population; establish a biobank to screen for biomarkers; and use radiomics analysis to identify characteristics of sensitive populations.

Conditions

Renal Cell Carcinoma; RCC; Kidney Cancer

Keywords

Renal Cell Carcinoma; Stereotactic Ablative Radiotherapy (SABR); Systemic Treatment; Toxicity; Curative Effect

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  K-M survival curves

  Through study completion, an average of 2 year

Secondary Outcomes (5)

• 2 Years Progression-Free Surial

  For all the patients, the time from the index of treatment to 2 years

• 2 Years Overall Survival

  For all the patients, the time from the index of treatment to 2 years

• Life Quality Score

  Through study completion, an average of 2 year，at each follow-up visit，once a month.

• Pain Score

  Through study completion, an average of 2 year，at each follow-up visit，once a month.

• Acute Toxicity

  Through study completion, an average of 2 year，at each follow-up visit，once a month.

Study Arms (1)

Experimental group

EXPERIMENTAL

SBRT radiotherapy for all lesions/all metastatic lesions

Radiation: Stereotactic Ablative Radiotherapy (SABR)

Interventions

Stereotactic Ablative Radiotherapy (SABR) RADIATION

Without altering the patients' systemic treatment plans, patients who meet the inclusion criteria after MDT discussion will receive SBRT radiotherapy for all lesions/all metastatic lesions based on the guideline-recommended medications. The radiotherapy plan is based on the SABR-COMET protocol and Timmerman's constraints.

Experimental group

Eligibility Criteria

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

You may qualify if:

• : Patients with newly diagnosed M1 renal cancer or those with oligoprogression during systemic therapy, with no restrictions on the location or number of metastatic sites, but all metastatic sites must be evaluated by the radiation oncology department as safely able to receive a radical radiation dose (α/β value of 3, EQD2 ≥ 70Gy).
• : Age ≥ 18 years. 3: ECOG score of 0-3. 4: Confirmed renal malignancy by pathology or imaging examination, with no subtype restrictions.
• : Presence of evaluable lesions. 6: Patients with spinal cord compression or significant brain metastasis edema requiring surgical decompression can be enrolled after evaluation by the radiation oncology department if the aforementioned dose can be safely administered post-decompression.
• : Able to tolerate radiation therapy and standard systemic therapy (targeted therapy or targeted immunotherapy combination).
• : Expected survival \> 6 months. 9: Able to sign the informed consent form. 10: Has conditions for follow-up.

You may not qualify if:

• : Patients with other comorbidities that prevent the use or tolerance of targeted immunotherapy drugs, such as targeted immunotherapy drug allergies, active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrolled hypertension, grade III-IV cardiac dysfunction (NYHA criteria), severe hepatic and renal insufficiency (grade IV), etc.
• : Patients with other comorbidities that prevent tolerance of radiation therapy.
• : Complete response to first-line drug therapy (i.e., no treatable targets for SABR).
• : Previous history of radiation therapy to the same site. 5: Pregnant or lactating women. 6: Patients with other severe medical comorbidities that prevent participation in the study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

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

Central Study Contacts

Xiongjun Ye

CONTACT

+86 139 1038 0916; yexiongjun@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share