Spatially Fractionated Radiotherapy for Tumor Treatment
17 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
126
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Zhiyuan Xu, MD
- Telefonnummer: +86 0755-86913333
- E-post: xuzy@hku-szh.org
Studieorter
-
-
Guangdong
-
Shenzhen, Guangdong, Kina, 518053
- Rekrytering
- The University of Hong Kong - Shenzhen Hospital
-
Kontakt:
- Zhiyuan Xu, MD
- Telefonnummer: 18307555170
- E-post: xuzy@hku-szh.org
-
Kontakt:
- Yang Li, MD
- Telefonnummer: +86 0755-86913333
- E-post: yangl1@hku-szh.org
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Huvudutredare:
- Zhiyuan Xu, MD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: SFRT arm
Adding spatially fractionated radiotherapy (SFRT) to standard-of-care treatment.
|
spatially fractionated radiotherapy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number and percentage of participants with treatment-related grade ≥3 adverse events as assessed by CTCAE v5.0
Tidsram: 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.
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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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Objective response rate (ORR) as assessed by RECIST version 1.1
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
19 december 2024
Primärt slutförande (Beräknad)
1 december 2028
Avslutad studie (Beräknad)
1 december 2028
Studieregistreringsdatum
Först inskickad
11 juli 2026
Först inskickad som uppfyllde QC-kriterierna
17 augusti 2026
Första postat (Faktisk)
19 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- hkuszhCAMT2024078
Läkemedels- och apparatinformation, studiedokument
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Nej
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