NCT01759238

Chemoradiotherapy for Patients With Oligometastatic Colorectal Cancer

Capecitabine and Bevacizumab With Radiotherapy After 3-6 Months Chemotherapy for Patients With Oligometastatic Colorectal Cancer (OLGA Trial)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study tries to evaluate the role of chemoradiation with capecitabine and bevacizumab in oligometastatic patients neither being progressive nor resectable after chemotherapy.

Detailed description

Combining chemoradiation with an antiangiogenic agent has a strong biological rationale, and preclinical studies consistently show an increase in radiosensitization with combined treatment. It is well described that hypoxia or HIF-1 expression is associated with a lower radiation response and progression in solid tumors. Radiation itself induces transient tumor hypoxia, which in turn stimulates VEGF production and VEGFR-2 expression what may also serve as a paracrine proliferative stimulus that promotes out-of-field growth. The combination of radiotherapy with an antiangiogenic agent (e.g. bevacizumab) thus offers the potential to enhance the effect of radiation, and avoid further spread of disease. Furthermore, targeting tumor vasculature improves the delivery of cytotoxic drugs (e.g. capecitabine) leading to increased efficacy of chemoradiation. Combination with cytotoxic drugs could additionally limit treatment-induced hypoxia (Senan and Smit 2007; Mazeron, Anderson et al. 2011).

Conditions

• Colorectal Cancer
• Metastases

Interventions

Type	Name	Description
DRUG	Capecitabine	825mg/m2 per os bid
DRUG	Bevacizumab	7.5 mg/kg
RADIATION	Radiotherapy	(conventional or intensity-modulated and image-guided radiotherapy)

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-01-03
• Last updated: 2022-07-01

Locations

1 site across 1 country: Germany