Gastric CancerPhase 2TNT-SHORTNCT07101666
Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer
A Phase 2 study testing Short course radiation therapy in people with Gastric Cancer, run by Washington University School of Medicine at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Short course radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Oct 2026to 30 Apr 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Haeseong Park, M.D., 877-215-1230
Haeseong Park, M.D.
UCLA
Los Angeles, California, 90095
Ann Raldow, M.D., 310-825-9775
Ann Raldow, M.D.
Washington University School of Medicine
St Louis, Missouri, 63110
Patrick Grierson, M.D., Ph.D., 314-747-7689, grierson@wustl.edu
Patrick Grierson, M.D., Ph.D.
Moffitt Cancer Center
Tampa, Florida, 33612
Jessica Frakes, M.D., 855-903-1098
Jessica Frakes, M.D.
About this study
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.
- Conditions
- Gastric Cancer
- Being tested
- Short course radiation therapy, Standard of care neoadjuvant chemotherapy
- Keywords
- Gastric cancer, SCRT
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short course radiation therapyRadiation
Also called SCRT
25 Gy in 5 fractions
Standard of care neoadjuvant chemotherapyDrug
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 group | Role | What they receive |
|---|---|---|
| SCRT + SOC Neoadjuvant Chemotherapy | Experimental | 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). Receives: Radiation: Short course radiation therapy; Drug: Standard of care neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Secondary outcomes (1)
Rate of grade 3 or greater adverse events as defined by CTCAE v 5.0
Measured: From day 1 of SCRT through 12 months after surgery/definitive end of treatment (estimated to be 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start31 Oct 2026 (estimated)
- Primary completion30 Apr 2031 (estimated)
- Study completion30 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Grierson, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101666
- Sponsor's protocol ID
- 25-x143
- Acronym
- TNT-SHORT
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer
- ClinicalTrials.gov ID
- NCT07101666
- Acronym / sponsor ID
- TNT-SHORT / 25-x143
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, SCRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2031 (estimated)
- Study completion
- 30 Apr 2031 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCRT + SOC Neoadjuvant Chemotherapy | Experimental | Radiation: Short course radiation therapy, Drug: Standard of care neoadjuvant chemotherapyPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short course radiation therapyAlso: SCRT25 Gy in 5 fractions | Radiation | SCRT + SOC Neoadjuvant Chemotherapy |
| Standard of care neoadjuvant chemotherapyRecommended 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. | Drug | SCRT + SOC Neoadjuvant Chemotherapy |
Primary outcome
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)
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Grierson, M.D., Ph.D. principal investigator
Washington University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short course radiation therapy in people with Gastric Cancer, run by Washington University School of Medicine at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Grierson, M.D., Ph.D. (314-747-7689, grierson@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.