Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Washington University School of Medicine
Study ID
NCT07101666
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Short course radiation therapy — RADIATION
    25 Gy in 5 fractions
  • Standard of care neoadjuvant chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SCRT + SOC Neoadjuvant Chemotherapy
    Patients will be treated with short course radiation therapy (SCRT) followed by 4 months of standard of care (SOC) neoadjuvant chemotherapy. Patients will then undergo gastrectomy (if medically operable) or surveillance (if medically inoperable).

Primary Outcome Measure

Complete response (CR) rate [ 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) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095
Ann Raldow, M.D.
310-825-9775
Ann Raldow, M.D. (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Jessica Frakes, M.D.
855-903-1098
Jessica Frakes, M.D. (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Haeseong Park, M.D.
877-215-1230
Haeseong Park, M.D. (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Patrick Grierson, M.D., Ph.D.
[email protected]
314-747-7689
Patrick Grierson, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Hyun Kim, M.D. (PRINCIPAL_INVESTIGATOR)
Michael Waters, M.D., Ph.D. (SUB_INVESTIGATOR)
Carl DeSelm, M.D., Ph.D. (SUB_INVESTIGATOR)
Roheena Panni, M.D., Ph.D. (SUB_INVESTIGATOR)
Dominic Sanford, M.D. (SUB_INVESTIGATOR)
Natasha Leigh-Matijakovich, M.D. (SUB_INVESTIGATOR)
Kian-Huat Lim, M.D., Ph.D. (SUB_INVESTIGATOR)
Rama Suresh, M.D. (SUB_INVESTIGATOR)
Benjamin Tan, M.D. (SUB_INVESTIGATOR)
Esther Lu, Ph.D. (SUB_INVESTIGATOR)
Shawn Wu, Ph.D. (SUB_INVESTIGATOR)
David DeNardo, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
UCLA· Los Angeles, CAMoffitt Cancer Center· Tampa, FLDana Farber Cancer Institute· Boston, MAWashington University School of Medicine· St Louis, MO

Related Studies