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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02311439
Other study ID # LAP001
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received December 4, 2014
Last updated December 5, 2014
Start date October 2014
Est. completion date April 2017

Study information

Verified date December 2014
Source Assiut University
Contact Ahmed Mohamed, MSc
Phone 00201221657931
Email a_allamnafady@yahoo.co.uk
Is FDA regulated No
Health authority Ethical Authority, Faculty of Medicine, Assiut University, Egypt ':'
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
FOLFIRINOX + CRT
Induction 4 times chemotherapy, FOLFIRINOX regimen, consisted of Oxaliplatin at a dose of 85 mg/m2 D1, 2-hour I.V + Irinotecan 180 mg/m2 D1 90-minute I.V. + Leucovorin 200 mg/m2 2- hour I.V, D1,2 + (5-FU) dosed at 400 mg/m2, administered as an intravenous bolus on day 1 and day 2, followed by a continuous intravenous infusion of 600 /m2 over a 20- hours period on day 1 and day 2. Treatment will be administered every 2 weeks. G-CSF will be administrated according to the need. In non-progressed cases, will be followed by consolidation concurrent radiotherapy with capecitabine 625 mg/m2 BID. Radiotherapy : A fractionated dose of 50.4Gy /28 fractions/15 MeV photon energy generated by Dual-energetic Linear Accelerator.

Locations

Country Name City State
Egypt Assiut University Hospitals Asyut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Progression Free Survival 6 months after finishing protocol Yes
Other Number of Cases will have radical surgery 6 months after enrolment Yes
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability of FOLFIRINOX plus Concurrent Radiotherapy with Capecitabine will be carried out, using (CTCAE) Common Terminology Criteria for Adverse Events, Version 4.0 6 months after enrolment Yes
Secondary Tumor response will be carried out, using (RECIST) Response Evaluation Criteria In Solid Tumors, Version 1.1 6 months after enrolment Yes
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