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

NCT02311439 | Unknown Phase 2 DMC

• 1 other identifier: LAP001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Pancreas

Keywords

Locally advanced pancreatic cancer; Chemotherapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Tumor response

  6 months after enrolment

Other Outcomes (2)

• Progression Free Survival

  6 months after finishing protocol

• Number of Cases will have radical surgery

  6 months after enrolment

Study Arms (1)

FOLFIRINOX + CRT

EXPERIMENTAL

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

Interventions

FOLFIRINOX + CRT DRUG

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.

FOLFIRINOX + CRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, Asyut Governorate, 71516, Egypt

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Ahmed Mohamed, MSc

CONTACT

00201221657931; a_allamnafady@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 8, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: April 1, 2017
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

EG (1)