Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-28 @ 3:25 PM
Study NCT ID:
NCT05622357
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2022-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
Sponsor:
National Cancer Institute, Egypt
Organization:
Study Overview
Official Title:
Prospective Phase II Study of Hypofractionated Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2022-11
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:
The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are:
* Is total neoadjuvant treatment in this design safe \& tolerable?
* Impact of this design on treatment related outcomes in terms of pathological and clinical responses.
* Is total neoadjuvant treatment in this design safe \& tolerable?
* Impact of this design on treatment related outcomes in terms of pathological and clinical responses.
Detailed Description:
Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks
Study Oversight
Has Oversight DMC:
True
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?: