Clinical trial · Observational
Proton and Proton-Photon Hybrid Partial Stereotactic Ablative Boost Radiotherapy (P-SABR) for Unresectable Large Tumors
A Prospective, Multicenter, Observational Cohort Study of Proton and Proton-Photon Hybrid Partial Stereotactic Ablative Boost Radiotherapy (P-SABR) for Unresectable Large Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bulky Tumor | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Unresectable Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton-Photon Hybrid P-SABR | Radiation | — | UNRESOLVED |
| Proton P-SABR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A: Proton P-SABR
- description
- 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.
- interventionNames
- Radiation: Proton P-SABR
- label
- Cohort B: Proton-Photon Hybrid P-SABR
- description
- 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.
- interventionNames
- Radiation: Proton-Photon Hybrid P-SABR
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTBai Y, Gao XS, Qin SB, Chen JY, Su MM, Liu Q, Qin XB, Ma MW, Zhao B, Gu XB, Xie M, Cui M, Qi X, Li XY. Partial stereotactic ablative boost radiotherapy in bulky non-small cell lung cancer: a retrospective study. Onco Targets Ther. 2018 May 8;11:2571-2579. doi: 10.2147/OTT.S159538. eCollection 2018. PMID 29780250
- RESULTBai Y, Gao X, Qin S, Li S, Ma M, Cao X, Lyu F, Chen J, Qi X, Liu S, Gao Y, Li H, Li X, Li X, Ren X, Huang L. Partial Stereotactic Ablative Radiotherapy Boost Before Conventional Radiotherapy (P-SABR) for Large (> 5 cm) Unresectable Stage III Nonsmall Cell Lung Cancer. Thorac Cancer. 2025 Jan;16(2):e15514. doi: 10.1111/1759-7714.15514. Epub 2024 Dec 14. PMID 39673459