Status:
UNKNOWN
Induction Chemotherapy, FOLFIRINOX Followed With Concurrent Capecitabine and Radiation Therapy in Inoperable Locally Advanced Cancer of the Pancreas
Lead Sponsor:
Assiut University
Conditions:
Cancer of Pancreas
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
This prospective cohort, phase II, trial is studying induction chemotherapy combination, FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil (5-FU), for 4 cycles, fol...
Detailed Description
Design \& Methodology: 1. Nature of the study: It is ( prospective cohort study). 2. Study subjects: \*Target Population: Patients, fulfilling the inclusion criteria for the research, will be...
Eligibility Criteria
Inclusion
- Disease characteristics:
- Histological and radiological confirmation of locally advanced cancer pancreas
- Inoperable disease
- Disease must be able to be encompassed within a radical radiotherapy treatment volume
- Not metastatic
- Patient characteristics:
- ECOG performance status 0 or 1
- Life expectancy \> 3 months.
- Glomerular filtration rate ≥ 60 mL/min.
- WBC \> 3,000/mm³.
- Absolute neutrophil count \> 1,500/mm³.
- Hemoglobin \> 10.0 g/dL.
- Platelet count \> 100,000/mm³.
- Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
- Gamma-glutamyl-transferase \< 1.5 times ULN.
- Transaminases ≤ 1.5 times ULN.
- Bilirubin ≤ 1.5 times ULN.
- No medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease)
- Not pregnant or nursing.
- No other previous or current malignant disease likely to interfere with protocol treatment or comparisons
- No prior chemotherapy or radiotherapy.
Exclusion
- ECOG performance status \> 2
- Life expectancy \< 3 months.
- Glomerular filtration rate \< 30 mL/min.
- Absolute neutrophil count \< 1,500/mm³.
- Alkaline phosphatase \> 1.5 times upper limit of normal (ULN)
- Gamma-glutamyl-transferase \> 1.5 times ULN.
- Transaminases\>1.5 times ULN.
- Bilirubin \>1.5 times ULN.
- medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease)
- pregnant or nursing.
- prior chemotherapy or radiotherapy.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2017
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02311439
Start Date
October 1 2014
End Date
April 1 2017
Last Update
December 8 2014
Active Locations (1)
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1
Assiut University Hospitals
Asyut, Asyut Governorate, Egypt, 71516