Early Phase 1 Trial Investigating Postoperative Treatment Selection After Preoperative Chemotherapy for Gastric Cancers
Researchers are seeking to determine the feasibility of receiving either postoperative chemoradiation or chemotherapy, based on nodal status at surgery.
Principle Investigator: Brandon G. Smaglo, MD, FACP, Baylor College of Medicine, Houston, Texas
Description: This is an early phase 1 open-label, stratified, 2-arm trial. Initially, all enrolled patients will receive standard preoperative chemotherapy and surgical resection for gastric cancer. After initial treatment, patients with node-negative disease will receive standard postoperative chemotherapy and patients with node-positive disease will receive standard postoperative chemoradiation.
In order to be eligible, patients must have pathologically proven adenocarcinoma of the stomach or gastroesophageal (GE)-junction, stage M0, as established by both imaging and surgical pathologic staging, have previously completed 3 cycles of neoadjuvant chemotherapy, and have undergone a surgical resection with definitive intent. Furthermore, patients must be assessed and verified as good candidates for adjuvant chemotherapy or chemoradiation, have diagnostic biopsy tissue that is available for genetic testing, and must be older than 18 years and be able to provide informed consent.
The primary objective of this trial is to determine the feasibility of receiving either postoperative chemoradiation or chemotherapy, based on nodal status at surgery, following preoperative chemotherapy. The researchers are seeking, as a secondary end point, to evaluate the rate of cancer recurrence after nodal status is used as the basis for treatment assignment.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03515941.
Status: The trial is open and recruiting patients as of May 31, 2018. The estimated enrollment for the trial is 40 patients.
- Clinicaltrials.gov. Postoperative chemoradiation or chemotherapy after preoperative chemotherapy for gastric cancers (GABLE). NCT03515941. https://clinicaltrials.gov/ct2/show/NCT03515941. Accessed December 17, 2018.