Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030511
Status:
TERMINATED
Last Update Posted:
2012-07-16
First Post:
2002-02-14
Brief Title:
Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Phase II trial to study the effectiveness of combining radiation therapy with fluorouracil before surgery in treating patients who have primary or recurrent bile duct cancer
PURPOSE Phase II trial to study the effectiveness of combining radiation therapy with fluorouracil before surgery in treating patients who have primary or recurrent bile duct cancer
Detailed Description:
OBJECTIVES
Determine the pathologic response rate in patients with primary or recurrent biliary duct carcinoma treated with neoadjuvant radiotherapy and fluorouracil followed by surgical resection
Determine the tumor response morbidity failure patterns locoregional vs distant and survival in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients undergo radiotherapy once daily five days a week for 55 weeks Patients receive fluorouracil IV over 12 hours each day radiotherapy is administered Four to six weeks after completion of chemoradiotherapy patients undergo surgical resection Patients with residual disease after resection may undergo boost radiotherapy
Patients are followed every 12 weeks until disease progression and then every 16 weeks after disease progression
PROJECTED ACCRUAL A total of 20-47 patients will be accrued for this study within 25 years
Determine the pathologic response rate in patients with primary or recurrent biliary duct carcinoma treated with neoadjuvant radiotherapy and fluorouracil followed by surgical resection
Determine the tumor response morbidity failure patterns locoregional vs distant and survival in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients undergo radiotherapy once daily five days a week for 55 weeks Patients receive fluorouracil IV over 12 hours each day radiotherapy is administered Four to six weeks after completion of chemoradiotherapy patients undergo surgical resection Patients with residual disease after resection may undergo boost radiotherapy
Patients are followed every 12 weeks until disease progression and then every 16 weeks after disease progression
PROJECTED ACCRUAL A total of 20-47 patients will be accrued for this study within 25 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-05991 | None | None | None |