Feasibility Study of Chemoradiation, TRAstuzumab and Pertuzumab in Resectable HER2+ Esophageal Carcinoma
Status:
Completed
Trial end date:
2017-02-01
Target enrollment:
Participant gender:
Summary
Despite neoadjuvant chemoradiation regimens esophageal cancer remains a disease with poor
outcome. The clinical benefit of HER2 targeting with trastuzumab has been shown in the
setting of advanced disease and disease and safety of combining trastuzumab with
chemoradiation in the curative setting has been established. In breast cancer, the added
value of pertuzumab to standard treatment with trastuzumab has been shown both in the
neoadjuvant and the metastastic setting. Taken together, there is a sound rationale to
explore the combination of radiotherapy plus chemotherapy with trastuzumab and pertuzumab in
HER2+resectable esophageal cancer. However, since the number of HER2+ patients in this
setting is limited, and no data are available on the safety of this combination prior to
major surgery, we propose to first conduct a feasibility study with this treatment stratgy.
When the results of this study show that this treatment strategy is feasible, we will
subsequently design a prospective study with efficacy as primary endpoint.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)