Spatially Fractionated Radiotherapy for Tumor Treatment
ConditionRadiotherapy-Induced Immune Priming
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXu Zhi-yuan
About this trial
To explore the efficacy and toxicity of spatially fractionated radiotherapy in the treatment of tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a bulky solid tumor with a maximum diameter >4 cm or a refractory solid tumor.
Disqualifiers
Tumors involving hollow viscera that are considered to have a clinically significant risk of bleeding or perforation.
Patients with impaired consciousness or who are unable to care for themselves.
Trial design
Design model
Single group
Treatments tested in this trial
spatially fractionated radiotherapy
Radiationspatially fractionated radiotherapy
Treatment groups
126 Participants
are divided into 1 treatment groupGroup A: SFRT armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number and percentage of participants with treatment-related grade ≥3 adverse events as assessed by CTCAE v5.0
Safety will be assessed by the incidence of treatment-related adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The number and percentage of participants experiencing at least one treatment-related grade ≥3 adverse event during the specified assessment period will be reported. Treatment-related serious adverse events and grade 5 adverse events will also be summarized descriptively.Whether this study can be successfully executed and implemented.
Time frame
From initiation of spatially fractionated radiation therapy through 90 days after completion of radiotherapy2
Percentage of participants who successfully complete the planned spatially fractionated radiation therapy without treatment discontinuation due to treatment-related toxicity or technical inability to deliver the planned treatment
Feasibility will be assessed by the proportion of enrolled participants who successfully complete the protocol-specified spatially fractionated radiation therapy (SFRT). Successful completion is defined as delivery of the planned SFRT according to the protocol without premature discontinuation due to treatment-related toxicity or technical inability to deliver the planned treatment. The number and percentage of participants meeting this definition will be reported.
Time frame
From initiation through completion of the planned spatially fractionated radiation therapySecondary outcomes
1
Objective response rate (ORR) as assessed by RECIST version 1.1
Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR) in the irradiated target lesion(s), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The number and percentage of participants achieving CR or PR will be reported.
Time frame
From initiation of spatially fractionated radiation therapy until documented disease progression, initiation of subsequent anticancer therapy, death, or the end of follow-up, up to 2 years2
Local progression-free survival (LPFS) as assessed by RECIST version 1.1
Local progression-free survival (LPFS) is defined as the time from initiation of spatially fractionated radiation therapy to the first documented local progression of the irradiated target lesion(s), as assessed according to RECIST version 1.1, or death from any cause, whichever occurs first. Participants who are alive without documented local progression at the time of analysis will be censored at the date of their last evaluable tumor assessment. LPFS will be estimated using the Kaplan-Meier method.
Time frame
From initiation of spatially fractionated radiation therapy until local disease progression or death from any cause, up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xu Zhi-yuan
Lead sponsor
The University of Hong Kong-Shenzhen Hospital
Sponsor institution
Source ClinicalTrials.gov