Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)

Phase 2

Completed

• Conditions: Metastatic Pancreatic Cancer; Cancer of Pancreas; Chemotherapy Effect
• Interventions: Drug: Gemcitabine fluorouracil

• Registration Number: NCT04769414
• Lead Sponsor: Menoufia University

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.

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 Timeline

• Study First Submitted: 2021-02-19
• Study Start: 2021-02-20
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-24
• Primary Completion: 2022-07-09
• Study Completion: 2022-07-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Gemcitabine fluorouracil	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

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	6 months from enrollment	describes according to RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Adverse events (AE)	6 months from chemotherapy	Describes according to CTCAE
Overall survival (OS)	One year from start of enrollment	The time interval between the date of diagnosis till the date of death
Progression free survival (PFS)	One year from start of enrollment	The time interval between the date of metastasis to the date of next disease progression

Trial Locations

Locations (1)

Menoufia University, Faculty of medicine; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt