Induction Chemotherapy, FOLFIRINOX Followed With Concurrent Capecitabine and Radiation Therapy in Inoperable Locally Advanced Cancer of the Pancreas

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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, followed by consolidation concurrent radiotherapy with capecitabine in non-progressed cases, in treating patients with locally advanced cancer pancreas.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Capecitabine; Fluorouracil; Folfirinox; Irinotecan; Oxaliplatin; Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.