Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003237
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy After Surgery in Treating Patients With Cancer of the Esophagus or Stomach
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Trial of Post-Operative Adjuvant Paclitaxel Cisplatin in Patients With Adenocarcinoma of the Esophagus Gastro-Esophageal Junction or Cardia
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them after surgery may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin given after surgery in treating patients with cancer of the esophagus or stomach
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin given after surgery in treating patients with cancer of the esophagus or stomach
Detailed Description:
OBJECTIVES I Evaluate the disease free survival and overall survival of patients with adenocarcinoma of the esophagus gastroesophageal junction or cardia receiving post-operative adjuvant paclitaxel plus cisplatin
OUTLINE Patients undergo esophagogastrectomies within 4-12 weeks prior to the study Patients receive intravenous paclitaxel over 3 hours on day 1 followed by intravenous cisplatin Treatment is repeated every 21 days for 4 courses Patients exhibiting disease recurrence or unacceptable toxic effects are removed from the study Patients are followed every 3 months for 2 years every 6 months for the next 3 years and then every 12 months thereafter
PROJECTED ACCRUAL A total of 55 patients will be accrued within 16 months
OUTLINE Patients undergo esophagogastrectomies within 4-12 weeks prior to the study Patients receive intravenous paclitaxel over 3 hours on day 1 followed by intravenous cisplatin Treatment is repeated every 21 days for 4 courses Patients exhibiting disease recurrence or unacceptable toxic effects are removed from the study Patients are followed every 3 months for 2 years every 6 months for the next 3 years and then every 12 months thereafter
PROJECTED ACCRUAL A total of 55 patients will be accrued within 16 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 |
|---|---|---|---|
| E-8296 | None | None | None |