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 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.
PRIMARY OBJECTIVE: I. To assess the safety and tolerability of preoperative short-course chemoradiotherapy (CXRT) in patients with potentially resectable gastric 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 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. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Given PO
Given IV
Undergo radiation therapy
Undergo standard of care surgery
M D Anderson Cancer Center
Houston, Texas, United States
Incidence of adverse events
Characterized by the incidence and severity of treatment-related adverse events. Grade 3 or higher toxicity classified as attributable to chemotherapy and radiation treatment (CXRT), during the 14 days of treatment administration or within 14 days of completion of CXRT (i.e., a total of 28 days), based on multidisciplinary review, will be used for the purpose of toxicity monitoring. Differences between grades vary and are detailed according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. In general, Grade 3 toxicity refers to any event that requires hospitalization with intervention (i.e., intravenous \[IV\] hydration, symptomatic control, transfusion, procedure, etc.).
Time frame: Up to 4 weeks following last chemotherapy
Rate of pathologic complete response in patients treated with resection
Will be estimated, along with exact 95% confidence intervals.
Time frame: Up to 5 years
Rate of perioperative complications after gastrectomy in patients treated with preoperative short course CXRT and chemotherapy
Will be estimated, along with exact 95% confidence intervals.
Time frame: Up to 5 years
Overall survival (OS)
Will be evaluated using the Kaplan-Meier method. Median OS and the 95% confidence interval will be reported.
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.