Standard treatment for patients with early stage gastric cancer consists of perioperative chemotherapy and surgical resection. If radiation therapy is administered in the adjuvant setting, the radiated area is often large and associated with significant toxicity. In this study, the investigators propose the addition of short course radiation therapy (SCRT) to chemotherapy in the neoadjuvant setting. The investigators hypothesize that this regimen of Total Neoadjuvant Therapy (TNT) will result in a higher rate of complete response (both pathologic and clinical), with less toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
25 Gy in 5 fractions
Recommended options are CAPOX, FOLFOX, or FLOT but other standard of care chemotherapy may be given given at the discretion of the treating medical oncologist after consultation with the study Principal Investigator.
UCLA
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Complete response (CR) rate
Complete response is defined as pathologic complete response (pCR) in operable patients and durable (1-year) clinical complete response (cCR) in medically inoperable patients. * pCR in operable patients is defined as no tumor on gastrectomy specimen. * Clinical complete response rate in inoperable patients is defined as having no evidence of disease on EUS and/or EGD and no definite evidence of disease on PET/CT.
Time frame: Through completion of surgery (estimated to be 6 months) for operable patients or through 12 months after end of treatment for inoperable patients (estimated to be 18 months)
Rate of grade 3 or greater adverse events as defined by CTCAE v 5.0
Time frame: From day 1 of SCRT through 12 months after surgery/definitive end of treatment (estimated to be 18 months)
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