NCT06311955

Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymus Tumor With Residual Tumor

Prospective Phase II Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymic Epithelial Malignant Tumor Received R2 Resection

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (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 heavy ion radiation therapy for locally advanced or advanced primary thymic epithelial malignant tumor received R2 resection. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was local relapse-free survival, overall survival and cause-specific survival.

Detailed description

The patients will receive 72GyE per 18 fractions of carbon ion radiotherapy. Patients with thymus cancer should be combined with platinum-based regimen (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin; paclitaxel combined with cisplatin or 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 local relapse-free survival, overall survival and cause-specific survival.

Conditions

• Thymic Epithelial Tumor
• Radiotherapy Side Effect
• Carbon Ion Radiotheray
• Heavy Ion Radiotherapy

Interventions

Type	Name	Description
RADIATION	Carbon ion radiotherapy	The patients will receive 72GyE per 18 fractions of carbon ion radiotherapy. Patients with thymus cancer should be combined with platinum-based regimen (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin; paclitaxel combined with cisplatin or 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 local relapse-free survival, overall survival and cause-specific survival.
OTHER	combined with platinum-based regimen	combined with platinum-based regimen

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-02-28
• Completion: 2029-02-28
• First posted: 2024-03-15
• Last updated: 2025-06-13

Locations

1 site across 1 country: China