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Completed

NCT Number: NCT04769414

Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine fluorouracil

Drug

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

Primary outcomes

  1. Overall response rate (ORR)

    Time frame: 6 months from enrollment

    describes according to RECIST criteria

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

A Phase II Trial of Flouro-Gem as a First Line Treatment of Metastatic Adenocarcinoma of the Pancreas (GEFLUPAN)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2021
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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