NCT00973609

Optimal Maintenance Therapy With Bevacizumab After Induction in Metastatic Colorectal Cancer (CRC)

Randomized Three Arm Phase III Trial on Induction Treatment With a Fluoropyrimidine-, Oxaliplatin- and Bevacizumab-based Chemotherapy for 24 Weeks Followed by Maintenance Treatment With a Fluoropyrimidine and Bevacizumab vs. Bevacizumab Alone vs. no Maintenance Treatment and Reinduction in Case of Progression for First-line Treatment of Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 853 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigating the efficacy of maintenance and reinduction treatment or no treatment and watchful waiting in subjects with inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy. The maintenance treatment with capecitabine or 5-FU/folinic acid and bevacizumab will be compared with a maintenance treatment with bevacizumab alone or no maintenance treatment. Reinduction treatment will be done in case of progression.

Detailed description

Chemotherapy and bevacizumab represent a standard of care in treatment of metastatic colorectal cancer. Until now, continuation of chemotherapy - and bevacizumab - represents the standard of care in colorectal cancer treatment. However, since the OPTIMOX1 trial showed an equivalent duration of disease control for a de-escalation / maintenance / reintroduction strategy compared with a treatment until progression strategy for oxaliplatin-based chemotherapy, the question is whether this strategy might apply also to bevacizumab in combination with chemotherapy. Furthermore, with the introduction of bevacizumab, there are new options for a maintenance treatment which should be evaluated. As the continuation of chemotherapy plus bevacizumab until disease progression has to be regarded as standard of care, the question is whether a de-escalation of treatment intensity or even withdrawal of treatment ("drug holiday") after a certain treatment period will not be inferior with respect to resulting time with tumor control, but allow patients a period with less toxicity and gain of quality of life.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	5-Fluorouracil, Folic acid, Capecitabine; Bevacizumab	Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab. Following induction treatment regimen (for maintenance treatment): No maintenance treatment.
DRUG	5-Fluorouracil, Folic acid, Capecitabine; Bevacizumab	Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab. Following induction treatment regimen (for maintenance treatment): Fluoropyrimidine + Bevacizumab.
DRUG	5-Fluorouracil, Folic acid, Capecitabine; Bevacizumab	Induction (and reinduction) treatment regimen for 24 weeks: Fluoropyrimidine, oxaliplatin and bevacizumab. Following induction treatment regimen (for maintenance treatment): Bevacizumab monotherapy.

Timeline

• Start date: 2009-08-01
• Primary completion: 2014-12-01
• Completion: 2015-08-01
• First posted: 2009-09-09
• Last updated: 2015-09-01

Locations

1 site across 1 country: Germany