Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006094
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2000-08-03
Brief Title:
Oxaliplatin Fluorouracil and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Preoperative Oxaliplatin NSC 266046 5-Fluorouracil and External Beam Radiation Therapy in Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy radiation therapy and surgery may be a more effective treatment for cancer of the rectum Phase II trial to study the effectiveness of combining oxaliplatin fluorouracil and external-beam radiation therapy followed by surgery in treating patients who have locally advanced cancer of the rectum
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of oxaliplatin when combined with fluorouracil and external beam radiotherapy in patients with locally advanced adenocarcinoma of the rectum
Phase I closed to accrual effective 03272003 II Determine the pathological response rate in patients treated with this preoperative regimen and surgical resection
IIIDetermine the late toxicity of this preoperative regimen in these patients IV Determine in a preliminary manner the progression-free survival local control and overall survival in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study of oxaliplatin
Patients receive oxaliplatin IV over 1 hour on day 1 fluorouracil IV continuously on days 1-7 and radiotherapy on days 1-5 Treatment repeats weekly for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at that dose level in the phase II portion of the study Phase I closed to accrual effective 03272003 Patients may undergo radical resection of rectal tumor within 4-6 weeks after completion of chemoradiotherapy
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 9-24 patients will be accrued for phase I of the study phase I closed to accrual effective 03272003 and a total of 19 patients will be accrued for phase II of the study within 12-18 months
I Determine the maximum tolerated dose of oxaliplatin when combined with fluorouracil and external beam radiotherapy in patients with locally advanced adenocarcinoma of the rectum
Phase I closed to accrual effective 03272003 II Determine the pathological response rate in patients treated with this preoperative regimen and surgical resection
IIIDetermine the late toxicity of this preoperative regimen in these patients IV Determine in a preliminary manner the progression-free survival local control and overall survival in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study of oxaliplatin
Patients receive oxaliplatin IV over 1 hour on day 1 fluorouracil IV continuously on days 1-7 and radiotherapy on days 1-5 Treatment repeats weekly for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at that dose level in the phase II portion of the study Phase I closed to accrual effective 03272003 Patients may undergo radical resection of rectal tumor within 4-6 weeks after completion of chemoradiotherapy
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 9-24 patients will be accrued for phase I of the study phase I closed to accrual effective 03272003 and a total of 19 patients will be accrued for phase II of the study within 12-18 months
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 |
|---|---|---|---|
| CDR0000068099 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-89901 | None | None | None |
| U10CA031946 | NIH | None | None |