Postoperative Chemoradiation or Chemotherapy After Preoperative Chemotherapy for Gastric Cancers
Status:
Terminated
Trial end date:
2020-06-18
Target enrollment:
Participant gender:
Summary
This is an open-label, stratified, two arm design. All patients receive same initial standard
preoperative chemotherapy and surgical resection. Patients will then be assigned to either
standard postoperative chemotherapy if node negative at surgery or standard postoperative
chemoradiation if node positive at surgery.
The primary objective of this study is to determine the feasibility of patients enrolling and
receiving either postoperative chemoradiation or chemotherapy alone, based upon nodal status
at surgery, following preoperative chemotherapy.
The secondary Objectives is to evaluate the rate of cancer recurrence in patients assigned to
treatment based upon node status. To explore the potential correlation between changes in
expression of a pre-specified panel of genes identified as relevant to gastrointestinal
cancers in response to preoperative chemotherapy, using presence of nodal involvement at time
of surgery as an indicator of response.