Spatially Fractionated Radiotherapy for Tumor Treatment
17. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
126
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Zhiyuan Xu, MD
- Telefonnummer: +86 0755-86913333
- E-post: xuzy@hku-szh.org
Studiesteder
-
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Guangdong
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Shenzhen, Guangdong, Kina, 518053
- Rekruttering
- The University of Hong Kong - Shenzhen Hospital
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Ta kontakt med:
- Zhiyuan Xu, MD
- Telefonnummer: 18307555170
- E-post: xuzy@hku-szh.org
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Ta kontakt med:
- Yang Li, MD
- Telefonnummer: +86 0755-86913333
- E-post: yangl1@hku-szh.org
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Hovedetterforsker:
- Zhiyuan Xu, MD
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: SFRT arm
Adding spatially fractionated radiotherapy (SFRT) to standard-of-care treatment.
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spatially fractionated radiotherapy
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. desember 2024
Primær fullføring (Antatt)
1. desember 2028
Studiet fullført (Antatt)
1. desember 2028
Datoer for studieregistrering
Først innsendt
11. juli 2026
Først innsendt som oppfylte QC-kriteriene
17. august 2026
Først lagt ut (Faktiske)
19. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- hkuszhCAMT2024078
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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