Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-30 @ 12:42 AM
Study NCT ID:
NCT06162650
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Neoadjuvant Therapy in Rectal Cancer
Sponsor:
National Cheng-Kung University Hospital
Organization:
Study Overview
Official Title:
A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
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:
In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.
Detailed Description:
This is a single center, single-arm, open-label, phase II study to investigate the efficacy and toxicities of total neoadjuvant therapy in patients with middle or lower rectal cancer. This study is planned to start after the approval by IRB, enroll patients for 2 years, and follow the clinical outcome for another 5 years. It will be conducted at National Cheng Kung University Hospital. Forty-two subjects will be enrolled. Patients who have newly diagnosed stage II or III, middle or low rectal adenocarcinoma will be recruited to receive the TNT treatment. The TNT includes the short-course radiotherapy (5×5 Gy over a maximum of 8 days)) followed by chemotherapy with the regimen of mFOLFOX6 for total 9 cycles
Study Oversight
Has Oversight DMC:
False
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?: