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Phase I/II Clinical Study of Helical Tomotherapy (TOMO) Whole Abdominopelvic Irradiation Combined with Simultaneous Integrated Boost for Radiosensitive Bone and Soft Tissue Sarcomas with Abdominopelvic Involvement

Phase I/II Clinical Study of Helical Tomotherapy (TOMO) Whole Abdominopelvic Irradiation Combined with Simultaneous Integrated Boost for Radiosensitive Bone and Soft Tissue Sarcomas with Abdominopelvic Involvement

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125250
Enrollment
Unknown
Registered
2026-05-22
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Bone and soft tissue sarcoma

Interventions

Helical Tomotherapy (TOMO) Low-dose Whole Abdominopelvic Irradiation Combined with Simultaneous Integrated Boost Group:1. Whole abdominopelvic baseline dose: 15 Gy/10 fractions (1.5 Gy/fraction) for p
sequential boost to =45 Gy/25 fractions if SIB is not feasible

Sponsors

Peking University Shougang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 39 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed highly radiosensitive bone/soft tissue sarcoma, including desmoplastic small round cell tumor (DSRCT), Ewing sarcoma, rhabdomyosarcoma, myxoid liposarcoma, etc. 2. Imaging-confirmed abdominopelvic involvement (metastasis, peritoneal seeding, malignant ascites, tumor rupture, or intraoperative contamination requiring whole abdominopelvic radiotherapy). 3. Age 6–39 years (including pediatric, adolescent, and young adult populations). 4. Karnofsky Performance Status (KPS) >=60%. 5. Expected survival >=3 months. 6. Adequate cardiopulmonary, hepatic, and renal function to tolerate radiotherapy (e.g., FEV1 >=50% predicted, NYHA class I–II, normal or mildly abnormal organ function). 7. Informed consent signed by the patient or legal representative.

Exclusion criteria

Exclusion criteria: 1. Previous abdominal/pelvic radiotherapy with unacceptable risk of normal tissue injury. 2. Active infection, uncontrolled diabetes, severe hypertension, unstable angina, heart failure, or other severe comorbidities. 3. Uncontrolled massive malignant ascites, complete intestinal obstruction, or active gastrointestinal bleeding. 4. Severe hepatic/renal insufficiency (decompensated cirrhosis, chronic renal failure). 5. Pregnant or lactating women. 6. Mental or cognitive impairment, or inability to comply with treatment. 7. Concurrent participation in another interventional clinical study.

Design outcomes

Primary

MeasureTime frame
Incidence of grade >=3 acute non-hematological toxicities during treatment and within 3 months post-treatment;Incidence of all-grade acute and late toxicities;

Secondary

MeasureTime frame
Treatment planning success rate;Objective response rate (ORR);Disease control rate (DCR);Abdominopelvic progression-free survival (abPFS);Overall survival (OS);Patient quality of life (QoL);Target and organ-at-risk (OAR) dosimetric parameters;

Countries

China

Contacts

Public ContactYuanyou Yang

Peking University Shougang Hospital

beijingyangyuanyou@163.com+86 10 5783 0354

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026