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Clinical Study on Spatiotemporal Fractionated Whole-Lung Irradiation with Helical Tomotherapy for Pulmonary Metastases from Ewing Sarcoma

Clinical Study on Spatiotemporal Fractionated Whole-Lung Irradiation with Helical Tomotherapy for Pulmonary Metastases from Ewing Sarcoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113217
Enrollment
Unknown
Registered
2025-11-26
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EwingSarcoma

Interventions

Treatment group:The intervention of this study is: the implementation of "spatiotemporal fractionated" whole lung irradiation using helical tomotherapy (TOMO) for patients with pulmonary metastases fr

Sponsors

Peking University Shougang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 34 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with Ewing's sarcoma by histopathological examination. 2. Patients with pulmonary metastasis confirmed by imaging (CT/MRI/PET-CT), with or without pleural, vertebral, or other metastases (regardless of initial treatment or recurrence), who require whole-lung irradiation radiotherapy. 3. Age >= 6 years and = 3 months. 6. Adequate cardiopulmonary, hepatic, and renal function to tolerate radiotherapy, as assessed by the following criteria: FEV1 >= 50% of predicted value; NYHA cardiac functional class I–II; Liver and kidney function within normal limits or with mild abnormalities that, in the investigator’s judgment, do not preclude radiotherapy. 7. The patient or their legal representative provides informed consent and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previously received chest radiotherapy, and the multidisciplinary team (MDT) assessment determined that it is no longer safe to undergo this full lung irradiation. 2. Present with active pulmonary infection, uncontrolled large pleural effusion or pericardial effusion. 3. Suffering from severe interstitial lung disease or severely impaired lung function (FEV1 < 50% of the predicted value). 4. Affected by any unstable systemic diseases, including active infection, uncontrolled hypertension, severe arrhythmia, heart failure (NYHA cardiac function classification III-IV grade), etc. 5. Pregnant or lactating women. 6. Having a psychological state that cannot complete radiotherapy, such as fear, anxiety (assessed by the researcher and confirmed by a psychiatrist).

Design outcomes

Primary

MeasureTime frame
Incidence of Grade >=3 Acute Radiation Pneumonitis;Objective Response Rate (ORR);Disease Control Rate (DCR);Lung Progression-Free Survival (LPFS);

Secondary

MeasureTime frame
Overall Survival (OS);Incidence of Acute Toxicities;Incidence of Late Toxicities;Safety of Combination Therapy (Incidence of Grade >=3 Adverse Events);

Countries

china

Contacts

Public ContactYang Yuanyou

Peking University Shougang Hospital

beijingyangyuanyou@163.com+86 136 2121 7196

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026