NCT03331640

A Health Service Research Study to Investigate Survival of Metastatic Pancreatic Cancer Patients After Sequential Chemotherapy

A Health Service Research Study to Investigate Survival of Metastatic Pancreatic Cancer Patients After Sequential Chemotherapy: An AIO Phase II Cross Over Trial (PANTHEON)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess the efficacy of second and third line therapies (OFF vs. FOLFIRI) in a sequential cross-over design in patients pretreated with nab-paclitaxel/gemcitabine first line.

Detailed description

Secondary objectives are assessment of safety and feasibility of the sequential cross-over treatment approach for advanced treatment lines in PDAC. 204 patients will be randomized into the treatments arms. Cross-over will take place after progress during second line therapy.

Conditions

• Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	OFF	OFF: 5-FU 2000 mg/m2 as 24 hour infusion + Na folinic acid 200 mg/m2 on D1, 8, 15, 22 Oxaliplatin 85 mg/m2 on D8, 22 3 weeks rest after D22; Cycle q42d
DRUG	FOLFIRI Protocol	Irinotecan 180 mg /m2 5-FU 400 mg/m2 (bolus) + 2400 mg/m2 as 46 hour infusion Na folinic acid 200 mg/m2 Cycle q2w

Timeline

• Start date: 2018-01-02
• Primary completion: 2021-09-13
• Completion: 2021-09-13
• First posted: 2017-11-06
• Last updated: 2022-01-11

Locations

1 site across 1 country: Germany