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Short Course Radiation Therapy for Gastric Cancer

This study is looking at a new way to treat gastric (stomach) cancer. It combines standard chemotherapy (like CAPOX, FOLFOX, or FLOT) with a short course of radiation therapy before surgery. This approach is called Total Neoadjuvant Therapy (TNT). Researchers want to see if this combination leads to more complete responses (meaning the cancer shrinks or disappears) and fewer side effects compared to current treatments. You might be able to join if you are an adult with newly diagnosed gastric adenocarcinoma that has not spread too far. The study aims to enroll 20 participants. The main goal is to measure how many people have a complete response to the treatment.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants to measure complete response through surgery (estimated 6 months) or for up to 12 months after treatment for inoperable patients (estimated 18 months).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07101666

Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Washington University School of Medicine
~20 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Short course radiation therapyStandard of care neoadjuvant chemotherapy

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response (CR) rate
Measured over 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)

Conditions

Gastric Cancer

Explore related trials

Gastric Carcinoma

Where it's being run

4 sites across 4 states
California1
Florida1
Massachusetts1
Missouri1

Study leadership

  • Patrick Grierson, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Patrick Grierson, M.D., Ph.D.
[email protected]
314-747-7689
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Newly diagnosed histologically or cytologically gastric adenocarcinoma. (Siewert III acceptable: the bulk of tumor should be in stomach; gastric tumors with extension to the gastroesophageal junction are permitted.) Patients with T1-4N0-3 are eligible.
Known T-stage defined by EUS. Must have had CT of the chest/abdomen/pelvis with IV contrast (or PET/CT if unable to receive iodinated contrast).
Medically eligible to receive SOC chemotherapy.
At least 18 years of age.
ECOG performance status ≤ 2.
Adequate bone marrow and organ function as defined below:
Absolute neutrophil count ≥ 1.5 K/cumm
Platelets ≥ 100 K/cumm
Creatinine clearance \> 50 mL/min by Cockroft Gault calculation
The effects of the various chemotherapy agents used in this study on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and one month after completion of the study.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion

Prior surgery, radiation, or chemotherapy for gastric or esophageal cancer.
Prior surgery to the esophagus or stomach.
Siewert I-II GE junction tumor.
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
Currently receiving any other investigational agents.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to the SOC chemotherapy used in the study.
Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that are considered clinically significant as determined by the treating physician.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of study entry.
HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.

What this trial measures

  • Complete response (CR) rateThrough 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)

    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.