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Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04769414
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Ahmed Sohaib, Menoufia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer of Pancreas Chemotherapy Effect Metastatic Pancreatic Cancer Drug: Gemcitabine fluorouracil Phase 2

Detailed Description:

Metastatic cancer pancreas has been a challenge for oncologists over the years. It is a disease of limited survival and a very poor response to treatment. The median overall survival at five years is expected to be between 4-6% only. Adenocarcinoma is the most common type of pancreatic cancer. It is the tenth most common adult solid malignancy. Most of the new therapeutic modalities has proven to be non-beneficial in this disease including targeted and immunotherapy.

For many years, the first line of treatment for pancreatic cancer was gemcitabine either alone or in combinations. Recently, FOLFIRINOX has become the standard of care due to its overall survival benefit. However, it is a small benefit on the expense of great toxicity.

Patients with metastatic cancer pancreas are recruited to receive the test regimen. Baseline evaluation will be done either by CT scan or PET/CT. re-evaluation will be repeated after 3 months of treatment and at end of 6 months

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Flouro-Gem as a First Line Treatment of Metastatic Adenocarcinoma of the Pancreas (GEFLUPAN)
Estimated Study Start Date : February 20, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Chemotherapy

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 6 months from enrollment ]
    describes according to RECIST criteria


Secondary Outcome Measures :
  1. Adverse events (AE) [ Time Frame: 6 months from chemotherapy ]
    Describes according to CTCAE

  2. Progression free survival (PFS) [ Time Frame: One year from start of enrollment ]
    The time interval between the date of metastasis to the date of next disease progression

  3. Overall survival (OS) [ Time Frame: One year from start of enrollment ]
    The time interval between the date of diagnosis till the date of death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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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): NCT04769414


Contacts
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Contact: Ahmed Sohaib, PhD +201060406063 ahmed.sohaib@med.menofia.edu.eg
Contact: Amira Hegazy, PhD +201090432337 amirahegazy28@yahoo.com

Locations
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Egypt
Menoufia University, Faculty of medicine Recruiting
Shebin Elkom, Menoufia, Egypt, 32511
Contact: Ahmed Sohaib, PhD    01060406063    dr.ahmed.sohaib@gmail.com   
Contact: Amira Hegazy, PhD    01090432337    amirahegazy28@yahoo.com   
Sub-Investigator: Reham Ahmed, PhD         
Sponsors and Collaborators
Menoufia University
More Information
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Publications:

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Responsible Party: Ahmed Sohaib, Lecturer of Clinical oncology, Menoufia University
ClinicalTrials.gov Identifier: NCT04769414    
Other Study ID Numbers: 352
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After publishing the primary results of the study, expected to be by January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Sohaib, Menoufia University:
pancreas
cancer
adenocarcinoma
metastatic
 gemcitabine
flourouracil
chemotherapy
first line
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
 Gemcitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs