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Randomized, phase II trial to assess hypofractionated post-operative radiotherapy vs. conventional post-operative radiotherapy after surgical resection of invasive thymic tumors

Randomized, phase II trial to assess hypofractionated post-operative radiotherapy vs. conventional post-operative radiotherapy after surgical resection of invasive thymic tumors

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067489
Enrollment
Unknown
Registered
2023-01-10
Start date
2023-01-10
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

thymic tumor

Interventions

conventional RT group:received conventional adjuvant radiotherapy (R0: 50Gy/25f
R1: 54Gy/27f
R2: 60-70Gy/30-35f)
moderately hypo-RT group:received adjuvant moderately hypofractionated radiotherapy (R0: 45Gy/15f
R1: 48Gy/16f
R2: 54-60Gy/18-20f)

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? pathologicaly diagnosed thymoma or thymic carcinoma ? received surgical resection a) R1,R2 resection b) For R0 resection, the thymoma stage should be Masaoka stage II-III; Thymic carcinoma has no requirement; ? Aged 18-75 ? KPS > 80 5. Cardiopulmonary function can tolerate surgery and radiotherapy

Exclusion criteria

Exclusion criteria: ? received induction chemotherapy ? received thoracic radiotherapy within 3 years ? complicated with other tumors or medical diseases that seriously affect prognosis ? inability to tolerate radiotherapy

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
disease-free survival;radiation pneumonitis;radiation esophagitis;radiation heart injury;relationship between parameters in preoperative PET-CT and survival;

Countries

China

Contacts

Public ContactDu Shisuo

Zhongshan Hospital, Fudan University

du.shisuo@zs-hospital.sh.cn13621830381

Outcome results

None listed

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