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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival

K-M survival curves

Time frame
Through study completion, an average of 2 year

Secondary outcomes

1

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

2 Years Overall Survival

K-M survival curves

Time frame
For all the patients, the time from the index of treatment to 2 years
3

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.
4

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: