Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215514
Status:
COMPLETED
Last Update Posted:
2014-07-29
First Post:
2005-09-20
Brief Title:
Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2014-07
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 main purpose of this trial is to determine how well patients with gastric or gastroesophageal junction adenocarcinoma respond to chemotherapy with epirubicin cisplatin and 5-fluorouracil followed by continuous infusion 5-fluorouracil chemotherapy given along with radiation therapy
Detailed Description:
Patients will receive epirubicin and cisplatin intravenously on day 1 of treatment 5-fluorouracil will be given continuously by intravenous infusion bia a portable ambulatory pump CADD pump for 21 days This cycle of chemotherapy will take 21 days 3 weeks Once it is complete there will be one week without therapy
Once the patient has recovered from any side-effects from the chemotherapy they will start the combination chemoradiation therapy 5-fluorouracil and radiation The radiation will be directed to the upper abdomen in the area where the stomach tumor has been located The radiation therapy will be given five days a week for a total of five weeks During these five weeks patients will receive 5-fluorouracil continuously by CADD pump
After completion of combination chemoradiation therapy there will be a three to four week rest period followed by 2 additional chemotherapy cycles identical to the first chemotherapy cycle
The following tests and procedures will be performed physical examination every 4 weeks except during the chemoradiation therapy when it will be done weekly blood tests every week during chemotherapy and chemoradiation CT scans and chest x-rays done before therapy at the end of therapy and yearly for 2 years noninvasive testing to evaluate kidney function before starting the study
The program of chemotherapy and radiation therapy will last approximately 30 weeks After all treatment is completed patients will return for physical examinations and blood tests every 3 months for 3 years then every 6 months for 2 years
Once the patient has recovered from any side-effects from the chemotherapy they will start the combination chemoradiation therapy 5-fluorouracil and radiation The radiation will be directed to the upper abdomen in the area where the stomach tumor has been located The radiation therapy will be given five days a week for a total of five weeks During these five weeks patients will receive 5-fluorouracil continuously by CADD pump
After completion of combination chemoradiation therapy there will be a three to four week rest period followed by 2 additional chemotherapy cycles identical to the first chemotherapy cycle
The following tests and procedures will be performed physical examination every 4 weeks except during the chemoradiation therapy when it will be done weekly blood tests every week during chemotherapy and chemoradiation CT scans and chest x-rays done before therapy at the end of therapy and yearly for 2 years noninvasive testing to evaluate kidney function before starting the study
The program of chemotherapy and radiation therapy will last approximately 30 weeks After all treatment is completed patients will return for physical examinations and blood tests every 3 months for 3 years then every 6 months for 2 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