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
    Recruiting
  • participants needed
    380
  • sponsor
    AIO-Studien-gGmbH
Updated on 17 June 2021
Investigator
Daniela Bein, Dr.
Primary Contact
St.-Antonius-Hospital Eschweiler (9.6 mi away) Contact
+1 other location
platelet count
measurable disease
carcinoma
fluorouracil
kidney function tests
metastasis
panitumumab
liver metastasis
adjuvant therapy
modified folfox6

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.

Details
Condition Metastatic Colorectal Cancer
Treatment Maintenance Chemotherapy, Panitumumab (Within maintenance phase), mFOLFOX6 (Within re-induction phase), Panitumumab (Within re-induction phase)
Clinical Study IdentifierNCT01991873
SponsorAIO-Studien-gGmbH
Last Modified on17 June 2021

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