Status:
COMPLETED
Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer
Lead Sponsor:
Henry Ford Health System
Conditions:
Pancreas Neoplasm Malignant Resectable
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in combination with chemo-radiation w...
Detailed Description
The primary objective is to evaluate frequency of achieving complete resection ( RO resection )in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regime...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma of the pancreatic head or body
- Patients must have radiographically-confirmed surgically resectable or borderline resectable disease at study entry staged at T1-3, NO-1 and MO
- Age \>/= 18years
- Life expectancy of greater than 6 months in the opinion of the investigator, excluding theh pancreatic cancer
- Eastern Cooperative Oncology Group (ECOG) performance status \</= 1
- Required laboratory data (see protocol)
- Disease assessment by CT scan within 4 weeks of study entry
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Patients may not be receiving any other investigational agent
- Patients with metastatic disease are excluded from this clinical trial
- History of allergic reactions attributed to Fluorouracil (5FU), oxaliplatin and gemcitabine
- No prior chemotherapy or radiation therapy for pancreatic cancer (previous chemotherapy or radiation therapy for other malignancies is permitted)
- Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study.
- Uncontrolled serious intercurrent illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breastfeeding women are excluded from this study.
- Known HIV-positive patients are ineligible
- Patients with unresectable disease are excluded form the protocol (see Appendix B for National Comprehensive cancer Network \[NCCN\] criteria for determining resectability status). Surgical resectability must be confirmed by a surgeon experienced in pancreatic surgery.
- Patients with pancreatic tail lesions will be excluded
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02243358
Start Date
February 1 2014
End Date
January 14 2020
Last Update
October 27 2023
Active Locations (1)
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1
Henry Ford Health System
Detroit, Michigan, United States, 48202