Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021320
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2001-07-11
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase II Evaluation Of Paclitaxel Cisplatin And 5-Fluorouracil Given In Combination With Radiation Therapy Prior To Surgery In Patients With Resectable Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2014-05
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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have esophageal cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have esophageal cancer
Detailed Description:
OBJECTIVES
Determine the median and two-year disease-free and overall survival of patients with resectable esophageal cancer treated with neoadjuvant paclitaxel cisplatin and fluorouracil with concurrent radiotherapy
Determine the complete and partial responses in patients treated with this regimen
Assess the toxicity of this regimen in these patients
Determine the optimal dose of paclitaxel when administered in this regimen in these patients
Determine the effect of tumor tubulin isoform expression on chemosensitivity and overall survival of patients treated with this regimen
OUTLINE Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 Treatment repeats every 3 weeks for 2 courses
Beginning 3 weeks after completion of initial chemotherapy patients receive concurrent chemoradiotherapy comprising paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 8 15 22 and 29 fluorouracil IV continuously for 5 weeks and radiotherapy daily 5 days a week for 5 weeks
At 4-8 weeks after completion of chemoradiotherapy patients may undergo surgical resection Patients with local progressive disease after 2 courses of initial chemotherapy undergo surgical resection instead of receiving concurrent chemoradiotherapy
Patients are followed within 6 weeks every 3 months for 3 years and then annually for 2 years
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study
Determine the median and two-year disease-free and overall survival of patients with resectable esophageal cancer treated with neoadjuvant paclitaxel cisplatin and fluorouracil with concurrent radiotherapy
Determine the complete and partial responses in patients treated with this regimen
Assess the toxicity of this regimen in these patients
Determine the optimal dose of paclitaxel when administered in this regimen in these patients
Determine the effect of tumor tubulin isoform expression on chemosensitivity and overall survival of patients treated with this regimen
OUTLINE Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 Treatment repeats every 3 weeks for 2 courses
Beginning 3 weeks after completion of initial chemotherapy patients receive concurrent chemoradiotherapy comprising paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 8 15 22 and 29 fluorouracil IV continuously for 5 weeks and radiotherapy daily 5 days a week for 5 weeks
At 4-8 weeks after completion of chemoradiotherapy patients may undergo surgical resection Patients with local progressive disease after 2 courses of initial chemotherapy undergo surgical resection instead of receiving concurrent chemoradiotherapy
Patients are followed within 6 weeks every 3 months for 3 years and then annually for 2 years
PROJECTED ACCRUAL A total of 14-30 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-G01-1982 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |
| FCCC-00003 | None | None | None |