Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Proton and Proton-Photon Hybrid Partial Stereotactic Ablative Boost Radiotherapy (P-SABR) for Unresectable Large Tumors (LARGE-Proton)

9 september 2026 bijgewerkt door: Xian-shu Gao, Peking University First Hospital

A Prospective, Multicenter, Observational Cohort Study of Proton and Proton-Photon Hybrid Partial Stereotactic Ablative Boost Radiotherapy (P-SABR) for Unresectable Large Tumors

This prospective, multicenter, observational cohort study will enroll 60 adults with unresectable larege tumors (longest diameter > 5 cm) who receive one of two treatment modes: (A) proton P-SABR, in which both the proton partial-SABR boost (course 1) and the subsequent proton CFRT (course 2) are delivered at the proton center; or (B) proton-photon hybrid P-SABR, in which course 1 is delivered with protons at the proton center and course 2 CFRT is delivered with photons. The primary objective is to describe, in each cohort, the incidence of treatment-related grade ≥ 3 acute and late adverse events (CTCAE v5.0). Secondary objectives are dosimetric and the 1-year local control rate (RECIST 1.1, in-field). Participants are followed for up to 5 years.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

BACKGROUND Large tumors (longest diameter > 5 cm) are often unresectable and respond poorly to conventionally fractionated radiotherapy (CFRT) because of their size and hypoxic core, while normal-tissue tolerance prevents delivering stereotactic ablative radiotherapy (SABR) to the whole tumor. Partial stereotactic ablative boost radiotherapy (P-SABR) delivers a SABR boost only to the central part of a large tumor, followed by CFRT to the whole target. Proton beams, with their Bragg-peak dose fall-off, may sharpen this "onion-skin" dose distribution and further increase the biologically effective dose (BED) within the tumor core.

DESIGN This prospective, multicenter, observational cohort study will enroll 60 adults with unresectable bulky tumors (longest diameter > 5 cm) who, as part of routine care, receive one of two treatment modes: (A) proton P-SABR, in which both the proton partial-SABR boost (course 1) and the subsequent proton CFRT (course 2) are delivered at the proton center; or (B) proton-photon hybrid P-SABR, in which course 1 is delivered with protons at the proton center and course 2 CFRT is delivered with photons (IMRT/VMAT) either at the same center or at Peking University First Hospital or one of six photon sub-centers, after central review of the composite plan. Cohort membership follows the patient's own choice and care pathway; the study does not assign treatment or intervene in clinical decisions, and no formal between-cohort hypothesis testing is planned.

OUTCOMES The primary objective is to describe, in each cohort, the incidence of treatment-related grade ≥ 3 acute and late adverse events (CTCAE v5.0). Secondary objectives are dosimetric (percentage of the GTV receiving BED10 ≥ 100 Gy, PTV V95% and V100%, organ-at-risk doses) and the 1-year local control rate (RECIST 1.1, in-field). Participants are followed for up to 5 years.

Studietype

Observationeel

Inschrijving (Geschat)

60

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adults with histologically or cytologically confirmed, unresectable bulky solid tumors (at least one lesion with longest diameter > 5 cm) who present to the radiation oncology departments of the participating centers, and who elect to receive proton P-SABR (Cohort A) or proton-photon hybrid P-SABR (Cohort B). Eligible patients are enrolled consecutively after written informed consent.

Beschrijving

Inclusion Criteria:

  • Histologically or cytologically confirmed malignancy
  • At least one tumor with a longest diameter > 5 cm
  • Not amenable to curative surgical resection, or patient declines surgery, or surgery contraindicated because of medical comorbidities
  • Age ≥ 18 years
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Written informed consent

Exclusion Criteria:

  • Prior radiotherapy to the same site
  • Severe cardiopulmonary insufficiency precluding radiotherapy
  • Concurrent other active malignancy
  • Uncontrolled acute infection or bowel obstruction
  • Pregnancy or breastfeeding
  • Intracranial lesion
  • Tumor directly invading the full thickness of the esophageal, gastric or intestinal wall with active ulceration, fistula or uncontrolled risk of perforation (tumors that only abut or displace a hollow organ without full-thickness invasion are not excluded)
  • Uncontrolled active tumor bleeding, or impending pathological fracture requiring orthopedic intervention
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Cohort A: Proton P-SABR
Participants who receive the entire P-SABR course with protons at Hebei Yizhou Cancer Hospital: course 1, proton partial stereotactic ablative boost (intensity-modulated proton therapy, IMPT); course 2, proton conventionally fractionated radiotherapy (CFRT). Planned enrollment: 30.
Straling: Proton P-SABR
Course 1 (proton partial-SABR boost, IMPT): CTV 1.8-3 Gy per fraction with a simultaneous boost to the boost volume within the GTV (GTVb) of 8 Gy × 3 fractions; in larger tumors the inner GTVb (GTVb shrunk by 1 cm) is further boosted to 12 Gy × 3 fractions; critical organs at risk < 3 Gy per fraction; robust optimization on the CTV. Course 2 (proton CFRT): CTV 1.8-3 Gy per fraction with robust optimization, to a cumulative PTV dose of 60-70 Gy on the summed plan, with GTVb BED10 ≥ 100 Gy. Proton dose is expressed with a constant RBE of 1.1. Both courses are delivered at Hebei Yizhou Cancer Hospital.
Andere namen:
  • Proton partial stereotactic ablative boost radiotherapy
  • Proton partial-SABR boost followed by proton conventionally fractionated radiotherapy
Cohort B: Proton-Photon Hybrid P-SABR
Participants who receive course 1 (proton partial stereotactic ablative boost, IMPT) at Hebei Yizhou Cancer Hospital, followed by course 2 photon conventionally fractionated radiotherapy (IMRT/VMAT with daily CBCT) delivered either at the same center (pathway A, same-center; planned n = 10) or at Peking University First Hospital or one of six photon sub-centers (pathway B, cross-center; planned n = 20) after central review of the composite plan. Planned enrollment: 30.
Straling: Proton-Photon Hybrid P-SABR
Course 1 identical to Cohort A: proton partial-SABR boost (IMPT) with GTVb 8 Gy × 3 fractions and inner GTVb 12 Gy × 3 fractions, delivered at Hebei Yizhou Cancer Hospital. Course 2 (photon CFRT): IMRT/VMAT with daily CBCT recommended, PTV 1.8-3 Gy per fraction to a cumulative PTV dose of 60-70 Gy on the summed plan, with GTVb BED10 ≥ 100 Gy, delivered at Hebei Yizhou Cancer Hospital (same-center) or at Peking University First Hospital or a photon sub-center (cross-center). For cross-center participants, DICOM-RT structure, plan and dose files of both courses are reviewed by the central radiotherapy QA committee, which performs deformable registration and dose summation (MIM; proton RBE = 1.1) before course 2 starts. Target interval between courses ≤ 3 working days (maximum 7 working days).
Andere namen:
  • Proton-photon hybrid partial stereotactic ablative boost radiotherapy
  • Proton partial-SABR boost followed by photon conventionally fractionated radiotherapy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of treatment-related adverse events of grade ≥ 3 (CTCAE v5.0)
Tijdsspanne: From the first fraction of radiotherapy to the end of the study
Up to 5 years after completion of radiotherapy (acute events: from the first fraction of radiotherapy through 90 days after completion; late events: from day 91 after completion through 5 years)
From the first fraction of radiotherapy to the end of the study

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of the gross tumor volume (GTV) receiving a biologically effective dose (BED10) ≥ 100 Gy
Tijdsspanne: Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
Volume fraction (%) of the GTV receiving BED10 ≥ 100 Gy on the composite (summed) plan, extracted from the treatment planning system (proton dose converted with RBE = 1.1; dose summation in MIM ).
Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
Planning target volume (PTV) coverage: V95% and V100%
Tijdsspanne: Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
Percentage of the PTV receiving ≥ 95% (V95%) and ≥ 100% (V100%) of the prescribed cumulative dose on the composite plan, reported per cohort as mean ± SD.
Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
Doses to organs at risk (OARs)
Tijdsspanne: Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
Dose metrics of organs at risk (e.g., spinal cord maximum dose, esophagus, lung, bowel, brachial plexus) on the composite plan, and the proportion of participants meeting each OAR dose constraint, reported per OAR and per cohort with 95% CI.
Up to 3 weeks after the first fraction of radiotherapy (when the composite plan of course 1 and course 2 is finalized)
1-year local control (LC) rate
Tijdsspanne: 12 months after the first fraction of radiotherapy
Local control is defined as the absence of progressive disease (RECIST 1.1) in in-field lesions; the in-field region is defined by the GTV/CTV/PTV projections exported from the treatment planning system (DICOM-RT) and confirmed by blinded central imaging review. Time to local progression is measured from the first fraction of radiotherapy. The 1-year LC rate and its Greenwood 95% CI are estimated per cohort with the Kaplan-Meier method; no between-cohort test is performed.
12 months after the first fraction of radiotherapy

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Peking University First Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 december 2029

Studie voltooiing (Geschat)

1 december 2029

Studieregistratiedata

Eerst ingediend

3 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 september 2026

Eerst geplaatst (Werkelijk)

14 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 september 2026

Laatste update ingediend die voldeed aan QC-criteria

9 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • LARGE-Proton-001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be made publicly available because of Chinese regulations on health data and human genetic resources. De-identified data may be shared with qualified researchers on reasonable request to the principal investigator, subject to ethics committee approval.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren