NCT04769414

Brief Summary

In this study, the investigators designed a treatment regimen including the most active agents in pancreatic cancer which are gemcitabine and fluorouracil to be tested as a first line treatment. This regimen is expected to be less toxic than FOLFIRINOX and aiming at better outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

February 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

February 19, 2021

Last Update Submit

August 5, 2022

Conditions

Cancer of PancreasChemotherapy EffectMetastatic Pancreatic Cancer

Keywords

pancreascanceradenocarcinomametastaticgemcitabineflourouracilchemotherapyfirst line

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR)

    describes according to RECIST criteria

    6 months from enrollment

Secondary Outcomes (3)

  • Adverse events (AE)

    6 months from chemotherapy

  • Progression free survival (PFS)

    One year from start of enrollment

  • Overall survival (OS)

    One year from start of enrollment

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Participants will receive the test protocol Gem-5FU on biweekly basis for 6 months with interim evaluation Doses as follows: Gemcitabine 1000 mg/m2, infusion over 30 min, D1, D15 Leucovorin 400 mg/m2 infusion over 30 min , D1, D15 5FU 400 mg/m2 I.V. shot D1, D15 5FU 2000 mg/m2 infusion over 46 hours D1 , D15

Drug: Gemcitabine fluorouracil

Interventions

Gemcitabine fluorouracilDRUG

chemotherapy protocol given as: * Gemcitabine 1000mg/m2 IV short infusion * Leucovorin 400 mg/m2 IV short infusion * Flourouracil 400 mg/m2 direct IV shot * Flourouracil 2000 mg/m2 contineous infusion over 46 hours The whole regimen will be repeated bi-weekly

Chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histopathological evidence of adenocarcinoma of the pancreas
  • Radiological proof of metastatic disease as defined by AJCC

You may not qualify if:

  • patients with poor performance status (ECOG 4)
  • patients with organ dysfunction defined as: creatinine more than 1.6 mg/dl or bilirubin more than 3 mg/dl
  • patients with end stage renal disease who are under regular dialysis
  • other histologies of pancreatic cancer
  • irresectable pancreatic cancer if not metatatic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University, Faculty of medicine

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

Related Publications (1)

  • Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

    PMID: 21561347BACKGROUND

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasmsAdenocarcinomaNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
Lecturer of Clinical oncology

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 24, 2021

Study Start

February 20, 2021

Primary Completion

July 9, 2022

Study Completion

July 9, 2022

Last Updated

August 8, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

IPD can be shared with other investigators upon personal contact with the PI of the study and after publishing the primary results. The investigators of this study are to be submitted as co-investigators in any other studies using the data of this study.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publishing the primary results of the study, expected to be by January 2023

Locations

EG(1)