Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165490
Status:
COMPLETED
Last Update Posted:
2014-11-10
First Post:
2005-09-09
Brief Title:
Combination Chemotherapy Radiation Therapy and Surgery for Esophageal Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Trial of Cetuximab Irinotecan Cisplatin CPC Concurrent Radiation Therapy and Surgery for Resectable Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2014-11
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:
The purpose of this study is to find out what effects good and bad the combination of three chemotherapy drugs cetuximab cisplatin and irinotecan have on esophageal cancer when given with radiation therapy
Detailed Description:
Patients participating in this study must have a tumor biopsy taken to confirm the type of tumor
Outpatient therapy with cetuximab alone will be given intravenously on week 0
During week 1-8 outpatient radiation therapy will be started and continued once per day for 28 treatments or 5 12 weeks
Outpatient chemotherapy cisplatin irinotecan and cetuximab is given once per week on weeks 1 2 4 and 5 Cetuximab alone will be given on weeks 3 6 7 and 8
A repeat CT scan and PET scan will be performed to restage the tumor on week 8 This is to confirm that the cancer has remained localized
Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and radiation therapy
Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6 months
During chemotherapy and radiation therapy physical exams and vital signs will be performed before each chemotherapy treatment Routine blood tests will also be performed
Between chemotherapy-radiation therapy and surgery a CAT scan of chest abdomen and pelvis along with a PET scan will be performed
After surgery a CAT scan of chest abdomen and pelvis will be performed every 3 months for 2 years then every 6 months for 3 years An EGD upper endoscopy with biopsy will be done every 6 months for 2 years and then yearly for 3 years Physical exam vital signs and routine blood tests will be done every 2 weeks for 6 months then every 3 months for 15 years and then every 6 months for 3 years
Outpatient therapy with cetuximab alone will be given intravenously on week 0
During week 1-8 outpatient radiation therapy will be started and continued once per day for 28 treatments or 5 12 weeks
Outpatient chemotherapy cisplatin irinotecan and cetuximab is given once per week on weeks 1 2 4 and 5 Cetuximab alone will be given on weeks 3 6 7 and 8
A repeat CT scan and PET scan will be performed to restage the tumor on week 8 This is to confirm that the cancer has remained localized
Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and radiation therapy
Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6 months
During chemotherapy and radiation therapy physical exams and vital signs will be performed before each chemotherapy treatment Routine blood tests will also be performed
Between chemotherapy-radiation therapy and surgery a CAT scan of chest abdomen and pelvis along with a PET scan will be performed
After surgery a CAT scan of chest abdomen and pelvis will be performed every 3 months for 2 years then every 6 months for 3 years An EGD upper endoscopy with biopsy will be done every 6 months for 2 years and then yearly for 3 years Physical exam vital signs and routine blood tests will be done every 2 weeks for 6 months then every 3 months for 15 years and then every 6 months for 3 years
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