Bevacizumab Maintenance Versus no Maintenance After Stop of First-line Chemotherapy in Patients With Metastatic Colorectal Cancer. A Randomized Multicenter Phase III Non-inferiority Trial
- To demonstrate that time to progression (TTP) without further treatment is not inferior
to TTP with maintenance therapy comprising bevacizumab in patients with metastatic
colorectal cancer and stable or responding disease after completion of standard
first-line chemotherapy/bevacizumab treatment.
- To evaluate the safety of bevacizumab maintenance therapy in these patients.
- To assess the long-term cost implications of prolonged treatment with bevacizumab.
OUTLINE: This is a multicenter study. Patients are stratified according to best response
during first-line chemotherapy/bevacizumab treatment (complete response and partial response
vs stable disease), duration of first-line treatment (16-20 weeks vs 21-24 weeks), type of
chemotherapy used during first-line treatment (irinotecan and fluoropyrimidine vs
oxaliplatin and fluoropyrimidine vs fluoropyrimidine monotherapy), disease burden (one organ
with metastasis vs more than one organ with metastasis), and by participating center.
- Arm I (bevacizumab maintenance therapy): Patients receive bevacizumab IV over 30
minutes on day 1. Treatment repeats every 21 days in the absence of disease progression
or unacceptable toxicity.
- Arm II (no maintenance therapy): Patients receive no further treatment; they are
monitored for disease progression.
After completion of study therapy or documentation of disease progression, patients are
followed every 3 months for 1 year and then every 6 months for up to 5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
From randomization until documented progressive disease or death due to tumor.
Dieter Koeberle, MD
Kantonsspital St. Gallen