Overview

Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer

Status:
Active, not recruiting

Trial end date:
2022-12-01

Target enrollment:

Participant gender:

Summary

This is a phase II, randomized, multi-center, open-label, parallel-group study to evaluate the progression-free survival during maintenance therapy. Eligible patients will be treated within a 12-week induction therapy. Those patients achieving CR/PR or SD at 12 weeks and qualifying for maintenance treatment and re-induction treatment with all potential drug components, will be randomized in a ratio of 1:1 to receive chemotherapy plus panitumumab or chemotherapy alone during maintenance. In case of progression, re-induction treatment will be started.

Phase:

Phase 2

Details

Lead Sponsor:

AIO-Studien-gGmbH

Collaborators:

Amgen
ClinAssess GmbH

Treatments:

Antibodies, Monoclonal
Fluorouracil
Folic Acid
Leucovorin
Levoleucovorin
Oxaliplatin
Panitumumab