NCT04769414

Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Cancer of Pancreas
• Chemotherapy Effect
• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-20
• Primary completion: 2022-07-09
• Completion: 2022-07-09
• First posted: 2021-02-24
• Last updated: 2022-08-08

Locations

1 site across 1 country: Egypt