Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04747951
Status:
UNKNOWN
Last Update Posted:
2021-02-15
First Post:
2021-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Total Neoadjuvant Therapy in Rectal Cancer Treatment
Sponsor:
State Scientific Centre of Coloproctology, Russian Federation
Organization:
Study Overview
Official Title:
Total Neoadjuvant Therapy in Rectal Cancer Treatment
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.
Detailed Description:
In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide "watch and wait" approach. Compliance of treatment and oncologic results will be the second endpoint.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: