RECRUITINGPhase 1Phase 2

Spatially Fractionated Radiotherapy for Tumor Treatment

To explore the efficacy and toxicity of spatially fractionated radiotherapy in the treatment of tumors.

Sponsor

Xu Zhi-yuan

Enrollment

126 participants

Sites

1 locations

Start Date

December 2024

Completion

December 2028

Radiotherapy-Induced Immune Primingspatially fractionated radiotherapy

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

126

participants

Sites

locations

Duration

4.0 years

total trial span

Rate

pts/month needed

Dec 2024Month 20 of 48Dec 2028

42% of trial timeline elapsed28 months to primary endpoint

At 1 sites, each site needs to enroll approximately 3.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

RECRUITINGPhase 1Phase 2

Spatially Fractionated Radiotherapy for Tumor Treatment

To explore the efficacy and toxicity of spatially fractionated radiotherapy in the treatment of tumors.

Sponsor

Xu Zhi-yuan

Enrollment

126 participants

Sites

1 locations

Start Date

December 2024

Completion

December 2028

Radiotherapy-Induced Immune Primingspatially fractionated radiotherapy

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

126

participants

Sites

locations

Duration

4.0 years

total trial span

Rate

pts/month needed

Dec 2024Month 20 of 48Dec 2028

42% of trial timeline elapsed28 months to primary endpoint

At 1 sites, each site needs to enroll approximately 3.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Number and percentage of participants with treatment-related grade ≥3 adverse events as assessed by CTCAE v5.0

From initiation of spatially fractionated radiation therapy through 90 days after completion of radiotherapy

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.

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

From initiation through completion of the planned spatially fractionated radiation therapy

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.

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

all

Healthy Volunteers

View full criteria

Inclusion Criteria:

* Patients with a bulky solid tumor with a maximum diameter \>4 cm or a refractory solid tumor.

Exclusion Criteria:

* 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.

Ask AI

Spatially Fractionated Radiotherapy for Tumor Treatment

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Spatially Fractionated Radiotherapy for Tumor Treatment

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Primary Outcomes

Eligibility

Trial Sites (1)