NCT06311968

The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor

Prospective Phase II Clinical Study of R0/R1 Post-operative Proton Radiation Therapy for Thymus Epithelial Malignancies

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Jian Chen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To observe the efficacy and toxicities of post-operative (R0/R1) proton radiotherapy for locally advanced primary thymus epithelial malignancies. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was overall survival and cause-specific survival.

Detailed description

Patients who received R0 resection will receive 45GyE per 18 fractions proton irradiation. Patients who received R1 resection will receive 50GyE per 20 fractions proton irradiation. Patients with thymus cancer should receive combined platinum based chemotherapy (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin, paclitaxel combined with cisplatin / carboplatin / loplatin / nedaplatin, Docetaxel combined with cisplatin / carboplatin / loplatin / nedaplatin) for at least 4 cycles. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was overall survival and cause-specific survival.

Conditions

• Thymus Epithelial Tumor
• Proton Radiotherapy
• Radiation Toxicity

Interventions

Type	Name	Description
RADIATION	Proton radiotherapy	Patients who received R0 resection will receive 45GyE per 18 fractions proton irradiation. Patients who received R1 resection will receive 50GyE per 20 fractions proton irradiation. Patients with thymus cancer should receive combined platinum based chemotherapy (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin, paclitaxel combined with cisplatin / carboplatin / loplatin / nedaplatin, Docetaxel combined with cisplatin / carboplatin / loplatin / nedaplatin) for at least 4 cycles.
OTHER	combined platinum based chemotherapy	combined platinum based chemotherapy

Timeline

• Start date: 2024-05-06
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2024-03-15
• Last updated: 2025-06-13

Locations

1 site across 1 country: China