Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408551
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2006-12-06
Brief Title:
Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver
Sponsor:
Goshen Health System
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Multi-Institutional Efficacy and Safety Study of Chemotherapy With Selective Internal Radiation Treatment Using Y-90 Microspheres CHEMO-SIRT in Patients With Colorectal Cancer Liver Metastasis
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
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 Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells Giving chemotherapy together with internal radiation may kill more tumor cells
PURPOSE This phase II trial is studying how well giving chemotherapy together with internal radiation works in treating patients with colorectal cancer that has spread to the liver
PURPOSE This phase II trial is studying how well giving chemotherapy together with internal radiation works in treating patients with colorectal cancer that has spread to the liver
Detailed Description:
OBJECTIVES
Primary
Evaluate the tumor response as measured by total tumor mass carcinoembryonic antigen CEA level measurable tumor volume by CT scan and metabolic response by positron emission tomography PET scan in patients with colorectal cancer metastatic to the liver undergoing chemotherapy and selective internal radiation therapy SIRT comprising yttrium Y 90 resin microspheres
Evaluate the hepatic toxicity of this regimen as measured by ALT alkaline phosphatase and bilirubin levels in these patients
Secondary
Evaluate the therapeutic efficacy of this regimen using time to in-liver disease progression as an end point in these patients
Evaluate the therapeutic efficacy of this regimen using down-staging to resectability as an end point in these patients
OUTLINE This is a multicenter study
Patients receive 1 of the following chemotherapy regimens
FOLFOX6 Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 Patients also receive fluorouracil IV continously over 46 hours beginning on day 1
FOLFIRI Patients receive irinotecan hydrochloride IV over 1 hour and leucovorin calcium IV over 2 hours on day 1 Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1
FUDR Patients receive floxuridine IV continuously on days 1-14 In all chemotherapy regimens treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Patients also undergo selective internal radiation therapy SIRT comprising yttrium Y 90 resin microspheres on day 2 of chemotherapy course 1 for patients receiving FOLFOX6 or FOLFIRI chemotherapy regimens or on day 1 2 3 4 or 5 of course 1 for patients receiving FUDR chemotherapy regimen SIRT may repeat in week 10 or 12
In week 18 patients may undergo surgery if down-staging has occurred or they may receive more chemotherapy
After completion of study therapy patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Primary
Evaluate the tumor response as measured by total tumor mass carcinoembryonic antigen CEA level measurable tumor volume by CT scan and metabolic response by positron emission tomography PET scan in patients with colorectal cancer metastatic to the liver undergoing chemotherapy and selective internal radiation therapy SIRT comprising yttrium Y 90 resin microspheres
Evaluate the hepatic toxicity of this regimen as measured by ALT alkaline phosphatase and bilirubin levels in these patients
Secondary
Evaluate the therapeutic efficacy of this regimen using time to in-liver disease progression as an end point in these patients
Evaluate the therapeutic efficacy of this regimen using down-staging to resectability as an end point in these patients
OUTLINE This is a multicenter study
Patients receive 1 of the following chemotherapy regimens
FOLFOX6 Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 Patients also receive fluorouracil IV continously over 46 hours beginning on day 1
FOLFIRI Patients receive irinotecan hydrochloride IV over 1 hour and leucovorin calcium IV over 2 hours on day 1 Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1
FUDR Patients receive floxuridine IV continuously on days 1-14 In all chemotherapy regimens treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Patients also undergo selective internal radiation therapy SIRT comprising yttrium Y 90 resin microspheres on day 2 of chemotherapy course 1 for patients receiving FOLFOX6 or FOLFIRI chemotherapy regimens or on day 1 2 3 4 or 5 of course 1 for patients receiving FUDR chemotherapy regimen SIRT may repeat in week 10 or 12
In week 18 patients may undergo surgery if down-staging has occurred or they may receive more chemotherapy
After completion of study therapy patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCCGHS-CHEMO-SIRT | None | None | None |