Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084591
Status:
COMPLETED
Last Update Posted:
2010-02-12
First Post:
2004-06-10
Brief Title:
Intensity-Modulated Radiation Therapy With Incorporated Boost and Capecitabine Before Surgery in Treating Patients With Locally Advanced Rectal Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase I Study of Preoperative Intensity Modulated Radiation Therapy IMRT With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2010-02
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:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Intensity-modulated radiation therapy radiation directed at the tumor more precisely than in standard radiation therapy with incorporated boost an increase in the amount of radiation given during treatment may cause less damage to normal tissue Drugs used in chemotherapy such as capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die Giving radiation therapy together with chemotherapy before surgery may shrink the tumor so it can be removed
PURPOSE This phase I trial is studying the side effects and best dose of neoadjuvant intensity-modulated radiation therapy with incorporated boost when given together with capecitabine in treating patients with locally advanced rectal cancer
PURPOSE This phase I trial is studying the side effects and best dose of neoadjuvant intensity-modulated radiation therapy with incorporated boost when given together with capecitabine in treating patients with locally advanced rectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of neoadjuvant boost intensity-modulated radiotherapy when combined with capecitabine before surgery in patients with locally advanced rectal cancer
Secondary
Determine the pathologic tumor response in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
OUTLINE This is a dose-escalation study of boost intensity-modulated radiotherapy IMRT
Patients undergo neoadjuvant IMRT with incorporated boost once daily 5 days a week for 5 weeks Beginning on the first day of radiotherapy patients receive oral capecitabine twice daily 7 days a week for 5 weeks Patients undergo surgical resection 4-8 weeks after completion of chemoradiotherapy
Cohorts of 3-6 patients undergo escalating doses of boost IMRT until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity
Quality of life is assessed at baseline at week 5 of chemoradiotherapy before surgery and then at 1 3 and 12 months after surgery
Patients are followed at 1 3 and 12 months after surgery
PROJECTED ACCRUAL Approximately 3-15 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of neoadjuvant boost intensity-modulated radiotherapy when combined with capecitabine before surgery in patients with locally advanced rectal cancer
Secondary
Determine the pathologic tumor response in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
OUTLINE This is a dose-escalation study of boost intensity-modulated radiotherapy IMRT
Patients undergo neoadjuvant IMRT with incorporated boost once daily 5 days a week for 5 weeks Beginning on the first day of radiotherapy patients receive oral capecitabine twice daily 7 days a week for 5 weeks Patients undergo surgical resection 4-8 weeks after completion of chemoradiotherapy
Cohorts of 3-6 patients undergo escalating doses of boost IMRT until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity
Quality of life is assessed at baseline at week 5 of chemoradiotherapy before surgery and then at 1 3 and 12 months after surgery
Patients are followed at 1 3 and 12 months after surgery
PROJECTED ACCRUAL Approximately 3-15 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| FCCC-03606 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |