Spatially Fractionated Radiotherapy for Tumor Treatment
17. august 2026 opdateret af: Xu Zhi-yuan
Spatially Fractionated Radiotherapy for Bulky or Refractory Solid Tumors: Efficacy and Toxicity
To explore the efficacy and toxicity of spatially fractionated radiotherapy in the treatment of tumors.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Spatially fractionated radiotherapy (SFRT) is a next-generation technology for precision cancer treatment.
It delivers a highly inhomogeneous dose distribution in three-dimensional space, demonstrating high clinical response rates and minimal toxicity in bulky primary or metastatic malignancies.
Conventional radiotherapy, which uniformly irradiates the entire tumor volume, often causes radiation damage to normal tissues, thereby limiting clinical efficacy.
In contrast, spatially fractionated radiotherapy divides the treatment volume into sub-volumes, alternating high-dose and low-dose regions among these sub-volumes.
Lattice radiotherapy is an advanced technique that integrates the technological advantages of radiosurgery and grid radiotherapy, achieving both biological and physical precision, and represents a novel radiotherapy approach for managing bulky and refractory tumors.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
126
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Zhiyuan Xu, MD
- Telefonnummer: +86 0755-86913333
- E-mail: xuzy@hku-szh.org
Studiesteder
-
-
Guangdong
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Shenzhen, Guangdong, Kina, 518053
- Rekruttering
- The University of Hong Kong - Shenzhen Hospital
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Kontakt:
- Zhiyuan Xu, MD
- Telefonnummer: 18307555170
- E-mail: xuzy@hku-szh.org
-
Kontakt:
- Yang Li, MD
- Telefonnummer: +86 0755-86913333
- E-mail: yangl1@hku-szh.org
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Ledende efterforsker:
- Zhiyuan Xu, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: SFRT arm
Adding spatially fractionated radiotherapy (SFRT) to standard-of-care treatment.
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spatially fractionated radiotherapy
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number and percentage of participants with treatment-related grade ≥3 adverse events as assessed by CTCAE v5.0
Tidsramme: From initiation of spatially fractionated radiation therapy through 90 days after completion of radiotherapy
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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.
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From initiation of spatially fractionated radiation therapy through 90 days after completion of radiotherapy
|
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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
Tidsramme: From initiation through completion of the planned spatially fractionated radiation therapy
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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.
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From initiation through completion of the planned spatially fractionated radiation therapy
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Objective response rate (ORR) as assessed by RECIST version 1.1
Tidsramme: 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 years
|
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.
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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 years
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Local progression-free survival (LPFS) as assessed by RECIST version 1.1
Tidsramme: From initiation of spatially fractionated radiation therapy until local disease progression or death from any cause, up to 2 years
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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.
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From initiation of spatially fractionated radiation therapy until local disease progression or death from any cause, up to 2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
19. december 2024
Primær færdiggørelse (Anslået)
1. december 2028
Studieafslutning (Anslået)
1. december 2028
Datoer for studieregistrering
Først indsendt
11. juli 2026
Først indsendt, der opfyldte QC-kriterier
17. august 2026
Først opslået (Faktiske)
19. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- hkuszhCAMT2024078
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