NCT05566743

A Study Evaluating Maintenance Therapy After First Line Chemotherapy in Metastatic Cancer Pancreas

A Randomized Phase II Study Evaluating Maintenance Therapy After First Line Induction Chemotherapy in Metastatic Cancer Pancreas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

A randomized phase II study evaluating maintenance therapy after first line induction chemotherapy in metastatic cancer pancreas.

Detailed description

In this study, we aim to evaluate the role of maintenance capecitabine by comparing 2 arms of metastatic cancer pancreas patients in the first line , the first arm will receive 4 months of induction FOLFRINOX the maintenance capecitabine and the second arm will receive 4 months of FOLFRINOX then kept under follow-up: •Primary end point: PFS. •Secondary end points: OS, QOL and Toxicity.

Conditions

• Cancer of Pancreas

Interventions

Type	Name	Description
DRUG	Capecitabine	maintenance capecitabine after 4 months of FOLFRINOX
OTHER	follow up	follow up after 4 months of FOLFRINOX

Timeline

• Start date: 2022-09-11
• Primary completion: 2023-09-11
• Completion: 2024-09-11
• First posted: 2022-10-04
• Last updated: 2022-10-04

Locations

3 sites across 1 country: Egypt