An interventional study of Stereotactic Ablative Radiotherapy (SABR) in Renal Cell Carcinoma, RCC and Kidney Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Not applicable, Interventional, and Treatment
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.
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.
1,992 studies on the registry are indexed under Carcinoma, Renal Cell; 387 are open to participants now.
This study's planned enrollment of 60 is above the median of 42 across 1,501 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 387 studies on the registry; 275 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
SBRT radiotherapy for all lesions/all metastatic lesions
Radiation: Stereotactic Ablative Radiotherapy (SABR)
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.
Progression-Free Survival
K-M survival curves
Time frame: Through study completion, an average of 2 year
2 Years Progression-Free Surial
K-M survival curves
Time frame: For all the patients, the time from the index of treatment to 2 years
2 Years Overall Survival
K-M survival curves
Time frame: For all the patients, the time from the index of treatment to 2 years
Life Quality Score
TESS score, scores range from 0 to 60, with higher values indicating better quality of life.
Time frame: Through study completion, an average of 2 year，at each follow-up visit，once a month.
Pain Score
VRS grading system, a five-point scale is used, with higher scores indicating more severe perceived pain.
Time frame: Through study completion, an average of 2 year，at each follow-up visit，once a month.
Acute Toxicity
Adopt CTCAE5.0 standard, a six-point scale is used, 0 to 5 scale, with higher scores indicating more severe adverse reaction.
Time frame: Through study completion, an average of 2 year，at each follow-up visit，once a month.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences →