Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425841
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2007-01-19
Brief Title:
Stereotactic Radiation Therapy and Combination Chemotherapy in Treating Patients Undergoing Surgery for Locally Advanced Pancreatic Cancer
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Lokal Fortgeschrittenes Pankreas-Karzinom Stereotaktische Radiotherapie Gefolfgt Von Gemox-Chemotherapie
Status:
COMPLETED
Status Verified Date:
2012-12
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 Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue Drugs used in chemotherapy such as gemcitabine and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving stereotactic radiation therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well giving stereotactic radiation therapy together with combination chemotherapy works in treating patients undergoing surgery for locally advanced pancreatic cancer
PURPOSE This phase II trial is studying how well giving stereotactic radiation therapy together with combination chemotherapy works in treating patients undergoing surgery for locally advanced pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the clinical response rate in patients undergoing surgery for locally advanced pancreatic cancer treated with stereotactic radiotherapy gemcitabine hydrochloride and oxaliplatin
Secondary
Determine the toxicity of this regimen in these patients
Determine the time to disease progression in patients treated with this regimen
Determine the time to death in patients treated with this regimen
Determine perioperative morbidity and mortality in patients treated with this regimen
Determine the rate of R0 resections in patients treated with this regimen
Determine the histologic response rate in these patients
OUTLINE
Neoadjuvant therapy Patients undergo hypofractionated stereotactic radiotherapy on days 1-5 Patients also receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 120 minutes on day 2 Treatment with gemcitabine hydrocloride and oxaliplatin repeats every 2 weeks for 3 courses
Surgery Patients with resectable disease undergo tumor resection Patients with unresectable disease undergo a second course of neoadjuvant chemoradiotherapy followed by resection
Adjuvant therapy Beginning 3-4 weeks after surgery patients receive 3 more courses of chemotherapy as in neoadjuvant therapy
After completion of study treatment patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 29 patients will be accrued for this study
Primary
Determine the clinical response rate in patients undergoing surgery for locally advanced pancreatic cancer treated with stereotactic radiotherapy gemcitabine hydrochloride and oxaliplatin
Secondary
Determine the toxicity of this regimen in these patients
Determine the time to disease progression in patients treated with this regimen
Determine the time to death in patients treated with this regimen
Determine perioperative morbidity and mortality in patients treated with this regimen
Determine the rate of R0 resections in patients treated with this regimen
Determine the histologic response rate in these patients
OUTLINE
Neoadjuvant therapy Patients undergo hypofractionated stereotactic radiotherapy on days 1-5 Patients also receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 120 minutes on day 2 Treatment with gemcitabine hydrocloride and oxaliplatin repeats every 2 weeks for 3 courses
Surgery Patients with resectable disease undergo tumor resection Patients with unresectable disease undergo a second course of neoadjuvant chemoradiotherapy followed by resection
Adjuvant therapy Beginning 3-4 weeks after surgery patients receive 3 more courses of chemotherapy as in neoadjuvant therapy
After completion of study treatment patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 29 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 |
|---|---|---|---|
| EU-20659 | None | None | None |
| KRDI-TUM-STRATEGIE-STR-242-LOR | None | None | None |