Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137852
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2005-08-29
Brief Title:
Cisplatin CPT-11 and Celecoxib With Radiation Therapy and Surgery for Operable Esophageal Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Trial of Cisplatin CPT-11 Celecoxib PCC Concurrent Radiation Therapy and Surgery for Resectable Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2017-09
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 is a study for patients with resectable locally advanced esophageal cancer There is evidence to suggest that celecoxib in combination with cisplatin and irinotecan CPT-11 may work well with radiation therapy to kill cancer cells The primary goal is to develop a well-tolerated cancer treatment that has an acceptable response rate
Detailed Description:
Patients will take celecoxib orally twice daily 3 days prior to radiation therapy and until one week prior to surgery Celecoxib will then be restarted when the patient is discharged from the hospital following surgery and continued for 26 weeks
Patients will receive chemotherapy cisplatin and irinotecan weekly on weeks 1 2 4 and 5 during radiation therapy Chemotherapy must occur on or before the fifth day of radiation therapy
Radiation therapy will be performed 5 days a week over a 56 week period
Patients will undergo an esophagectomy within 4-8 weeks of chemotherapyradiation therapy Technically accessible lymph nodes will also be removed
During chemotherapyradiation therapy a physical exam and bloodwork will be conducted weekly
Between chemotherapyradiation therapy and surgery a physical exam bloodwork and CT of chest abdomen and pelvis should be performed
After the completion of treatment and surgery a physical exam and bloodwork should be done every 6 weeks for 6 months then every 3 months for 1 12 years then every 6 months for 3 years
Patients will receive chemotherapy cisplatin and irinotecan weekly on weeks 1 2 4 and 5 during radiation therapy Chemotherapy must occur on or before the fifth day of radiation therapy
Radiation therapy will be performed 5 days a week over a 56 week period
Patients will undergo an esophagectomy within 4-8 weeks of chemotherapyradiation therapy Technically accessible lymph nodes will also be removed
During chemotherapyradiation therapy a physical exam and bloodwork will be conducted weekly
Between chemotherapyradiation therapy and surgery a physical exam bloodwork and CT of chest abdomen and pelvis should be performed
After the completion of treatment and surgery a physical exam and bloodwork should be done every 6 weeks for 6 months then every 3 months for 1 12 years 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