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

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

NCT ID: NCT06585878

Condition: Renal Cell Carcinoma
RCC
Kidney Cancer

Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms

Conditions: Keywords:
Renal Cell Carcinoma
Stereotactic Ablative Radiotherapy (SABR)
Systemic Treatment
Toxicity
Curative Effect

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Stereotactic Ablative Radiotherapy (SABR)
Description: 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.
Arm group label: Experimental group

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.

Detailed description: This study is a non-randomized, prospective, registry-based trial that aims to enroll 60 patients with renal cancer who will be diagnosed and treated at our hospital between May 2024 and May 2026. Without altering the patients' systemic treatment plans, those who meet the inclusion criteria after MDT discussion will receive SBRT (Stereotactic Body Radiation Therapy) for all lesions/all metastatic lesions in addition to the guideline-recommended medications. The radiotherapy plan is based on the SABR-COMET protocol and Timmerman's constraints. Patient data will be collected, including general clinical information, toxicity assessments during treatment and in the acute phase, detailed imaging data, regular assessments of pain and quality of life, and evaluations of late radiation therapy responses.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 1: 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). 2: Age ≥ 18 years. 3: ECOG score of 0-3. 4: Confirmed renal malignancy by pathology or imaging examination, with no subtype restrictions. 5: 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. 7: Able to tolerate radiation therapy and standard systemic therapy (targeted therapy or targeted immunotherapy combination). 8: Expected survival > 6 months. 9: Able to sign the informed consent form. 10: Has conditions for follow-up. Exclusion Criteria: - 1: 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. 2: Patients with other comorbidities that prevent tolerance of radiation therapy. 3: Complete response to first-line drug therapy (i.e., no treatable targets for SABR). 4: 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: September 1, 2024

Completion date: April 30, 2027

Lead sponsor:
Agency: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class: Other

Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06585878