Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006472
Status:
TERMINATED
Last Update Posted:
2020-08-18
First Post:
2000-11-06
Brief Title:
Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I Stage II or Stage III Esophageal Cancer
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Esophageal Cancer A Phase II Study of Paclitaxel Carboplatin and 5-Fluorouracil With Simultaneous Radiotherapy Followed by Surgical Resection
Status:
TERMINATED
Status Verified Date:
2002-02
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 Radiation therapy uses high-energy x-rays to damage tumor cells Giving chemotherapy drugs and radiation therapy before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy given before surgery in treating patients who have stage I stage II or stage III esophageal cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy given before surgery in treating patients who have stage I stage II or stage III esophageal cancer
Detailed Description:
OBJECTIVES I Determine the total response rate in patients with stage I II or III esophageal cancer treated with paclitaxel carboplatin and fluorouracil with concurrent radiotherapy followed by surgical resection II Determine the overall survival of these patients treated with this regimen II Determine the toxicity of this regimen in this patient population
OUTLINE Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1 and 22 and fluorouracil IV continuously on days 1-42 Patients undergo radiotherapy concurrently with chemotherapy daily 5 days a week for 5 weeks Patients then undergo surgical resection within 3-5 weeks following completion of therapy Patients are followed every 3 months for 6 months every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 47 patients will be accrued for this study
OUTLINE Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1 and 22 and fluorouracil IV continuously on days 1-42 Patients undergo radiotherapy concurrently with chemotherapy daily 5 days a week for 5 weeks Patients then undergo surgical resection within 3-5 weeks following completion of therapy Patients are followed every 3 months for 6 months every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 47 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-V00-1633 | None | None | None |
| WHC-99692 | None | None | None |