Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311968
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-09
Brief Title:
The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor
Sponsor:
Jian Chen
Organization:
Shanghai Proton and Heavy Ion Center
Study Overview
Official Title:
Prospective Phase II Clinical Study of R0R1 Post-operative Proton Radiation Therapy for Thymus Epithelial Malignancies
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To observe the efficacy and toxicities of post-operative R0R1 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None