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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311439
Recruitment Status : Unknown
Verified December 2014 by Ahmed Allam Abdelhamed Mohamed, Assiut University.
Recruitment status was:  Recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Ahmed Allam Abdelhamed Mohamed, Assiut University

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

Condition or disease Intervention/treatment Phase
Cancer of Pancreas Drug: FOLFIRINOX + CRT Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction Chemotherapy, Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) Followed With Concurrent Capecitabine and Radiation Therapy in Treatment of Patients With Inoperable Locally Advanced Cancer Pancreas
Study Start Date : October 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FOLFIRINOX + CRT
FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil (5-FU), for 4 cycles, followed by consolidation radiotherapy concurrent with capecitabine 625mg/m2 BID in non-progressed cases, in treating patients with locally advanced cancer pancreas.
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.





Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability of FOLFIRINOX plus Concurrent Radiotherapy with Capecitabine [ Time Frame: 6 months after enrolment ]
    will be carried out, using (CTCAE) Common Terminology Criteria for Adverse Events, Version 4.0


Secondary Outcome Measures :
  1. Tumor response [ Time Frame: 6 months after enrolment ]
    will be carried out, using (RECIST) Response Evaluation Criteria In Solid Tumors, Version 1.1


Other Outcome Measures:
  1. Progression Free Survival [ Time Frame: 6 months after finishing protocol ]
  2. Number of Cases will have radical surgery [ Time Frame: 6 months after enrolment ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311439


Contacts
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Contact: Ahmed Mohamed, MSc 00201221657931 a_allamnafady@yahoo.co.uk

Locations
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Egypt
Assiut University Hospitals Recruiting
Asyut, Egypt, 71516
Contact: Samir Eid, Professor       samir_eid@hotmail.com   
Sponsors and Collaborators
Assiut University
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Responsible Party: Ahmed Allam Abdelhamed Mohamed, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02311439    
Other Study ID Numbers: LAP001
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Ahmed Allam Abdelhamed Mohamed, Assiut University:
Locally advanced pancreatic cancer
Chemotherapy
Radiotherapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Folfirinox
Antineoplastic Agents