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Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study

NCT02148549 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-10-07

No results posted yet for this study

Summary

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen

Conditions

  • Patients With Borderline Resectable Pancreatic Cancer

Interventions

DRUG

FIRINOX

FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.

Sponsors & Collaborators

  • Wakayama Medical University

    lead OTHER

Principal Investigators

  • Hiroki Yamaue, M.D., PhD · Wakayama Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02148549 on ClinicalTrials.gov