Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04643366
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2020-11-18
Brief Title:
Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase 2 Study of Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-01
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:
This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer
Detailed Description:
This trial involves 4 cycles of systemic chemotherapy followed by short-course RT with concurrent 5-FU neoadjuvant chemoradiotherapy CRT and subsequent consolidation with 4 cycles of systemic chemotherapy prior to surgery or for those who achieve cCR the option of non-operative active surveillanceThree-year disease free survival DFS defined as the percentage of patients alive without recurrence of disease at 3 years measured from the date of clinical complete response cCR or date of total mesorectal excision TME at surgery whichever is earlier
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-13796 | OTHER | NCI CTRP | None |
| HM20020384 | OTHER | None | None |