This phase Ib trial investigates the side effects and how well a shorter course of chemotherapy and radiation treatment (chemoradiotherapy) for 2 weeks instead of 5 weeks followed by standard chemotherapy works in treating patients with gastric and gastroesophageal cancer who are scheduled to have treatment and then surgery to remove the tumor. Chemotherapy drugs, such as capecitabine and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving short-course chemo-radiotherapy before chemotherapy and surgery may help to control the disease.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04523818.
PRIMARY OBJECTIVE:
I. To assess the safety and tolerability of preoperative short-course chemoradiotherapy (CXRT) in patients with potentially resectable gastric and gastroesophageal adenocarcinoma.
SECONDARY OBJECTIVES:
I. To assess the rate of pathologic complete response (pathCR) in patients treated with preoperative short-course CXRT.
II. To assess the rate of perioperative complications after gastrectomy or esophagectomy in patients treated with preoperative short-course CXRT.
III. To assess overall survival from the date of diagnosis in subjects treated with short course CXRT.
IV. To determine the costs (financial toxicity) and time spent on treatment (time toxicity) for patients treated with short-course CXRT compared to a similar group of patients treated with traditional long-course CXRT.
OUTLINE:
Patients receive CXRT consisting of radiation therapy 5 days a week (Monday through Friday) for 2 weeks (10 treatments) and standard of care chemotherapy consisting of capecitabine orally (PO) twice daily (BID) or fluorouracil intravenously (IV) continuous Monday to Friday of each radiation week. About 2 weeks later, patients receive standard of care chemotherapy for up to 2 months in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery 3-8 weeks post-chemotherapy completion.
After the completion of study treatment, patients are followed up every 6 months for 5 years.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorBrian D. Badgwell
