A Prospective Registry Study of Stereotactic Ablative Radiotherapy (SABR) for Oligometastatic/Oli… (NCT06585878) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Prospective Registry Study of Stereotactic Ablative Radiotherapy (SABR) for Oligometastatic/Oligometastatic Renal Cell Carcinoma
60 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.…
What they're measuring
1
Progression-Free Survival
Timeframe: Through study completion, an average of 2 year
Trial details
NCT IDNCT06585878
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences