Ignite Creation Date:
2024-05-06 @ 3:22 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02270606
Status:
COMPLETED
Last Update Posted:
2021-07-20
First Post:
2014-10-16
Brief Title:
Phase I Study of Neoadjuvant Radiotherapy With 5-Fluorouracil for Rectal Cancer
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase I Study of Neoadjuvant Short Course Radiotherapy Concurrent With Infusional 5-Fluorouracil for the Treatment of Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2021-07
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 phase I trial studies the side effects and best dose of fluorouracil when given together with radiation therapy followed by combination chemotherapy before and after surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors Drugs used in chemotherapy such as fluorouracil leucovorin calcium and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving more than one drug combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving additional combination chemotherapy after surgery may kill any remaining tumor cells Giving radiation therapy and fluorouracil followed by combination chemotherapy before and after surgery may be a better treatment for rectal cancer
Detailed Description:
OUTLINE This is a dose-escalation study of fluorouracil
CHEMORADIATION Patients undergo intensity-modulated radiation therapy IMRT once daily QD over 5 days for a total of 5 fractions and concurrently receive fluorouracil intravenously IV continuously over 96 hours
PREOPERATIVE CHEMOTHERAPY Within 2 weeks of completing chemoradiation patients receive oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours and fluorouracil IV as a push followed by IV continuously over 46 hours on day 1 Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity
SURGERY Within 4-8 weeks of completing preoperative chemotherapy patients undergo total mesorectal excision
POSTOPERATIVE CHEMOTHERAPY Within 4-8 weeks after surgery patients receive oxaliplatin leucovorin calcium and fluorouracil as in preoperative chemotherapy Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 1 year or until removal from the study or death whichever occurs first
CHEMORADIATION Patients undergo intensity-modulated radiation therapy IMRT once daily QD over 5 days for a total of 5 fractions and concurrently receive fluorouracil intravenously IV continuously over 96 hours
PREOPERATIVE CHEMOTHERAPY Within 2 weeks of completing chemoradiation patients receive oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours and fluorouracil IV as a push followed by IV continuously over 46 hours on day 1 Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity
SURGERY Within 4-8 weeks of completing preoperative chemotherapy patients undergo total mesorectal excision
POSTOPERATIVE CHEMOTHERAPY Within 4-8 weeks after surgery patients receive oxaliplatin leucovorin calcium and fluorouracil as in preoperative chemotherapy Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 1 year or until removal from the study or death whichever occurs first
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2014-02089 | REGISTRY | None | None |
| P30CA016059 | NIH | NCI CTRP | httpsreporternihgovquickSearchP30CA016059 |