Short Course Radiation Therapy for Stomach Cancer

(TNT-SHORT Trial)

Not yet recruiting at 3 trial locations

Overseen By Patrick Grierson, M.D., Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: Investigational agents

Disqualifiers: Prior surgery, Uncontrolled illness, Pregnant, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for people with early-stage stomach cancer. Researchers aim to determine if adding a short course of radiation therapy before standard chemotherapy (neoadjuvant chemotherapy) can improve outcomes and reduce side effects. The goal is to see if this combination leads to a better complete response to treatment. Individuals newly diagnosed with stomach cancer who have not yet undergone surgery or chemotherapy might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on investigational agents or have uncontrolled illnesses, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that short course radiation therapy (SCRT) is safe for people with stomach cancer. Earlier research suggests that patients tolerate this treatment well when administered before surgery. In these studies, patients did not experience severe side effects that required stopping treatment.

Other findings indicate that SCRT can enhance treatment effectiveness. It might even allow some patients to avoid surgery if the cancer responds well. Overall, this treatment benefits patients without adding significant risk. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for stomach cancer?

Researchers are excited about the short course radiation therapy (SCRT) combined with standard of care neoadjuvant chemotherapy for stomach cancer because it offers a potentially quicker and more efficient treatment approach. Unlike typical neoadjuvant chemotherapy alone, which can take longer to shrink tumors, SCRT provides a concentrated dose of radiation in a shorter time frame, possibly enhancing the effectiveness of the chemotherapy that follows. This combination could lead to a more immediate reduction in tumor size, making surgery more feasible and improving outcomes for patients who are operable. Additionally, for those who are inoperable, this approach might offer a viable alternative by controlling tumor growth more aggressively.

What evidence suggests that short course radiation therapy could be an effective treatment for stomach cancer?

This trial will evaluate the combination of short course radiation therapy (SCRT) with standard of care neoadjuvant chemotherapy for stomach cancer. Research has shown that combining SCRT with chemotherapy can benefit people with stomach cancer. Studies have found that adding radiation therapy to chemotherapy can extend the time patients live without cancer recurrence, especially for those with certain types of stomach cancer. This combination is particularly beneficial for patients whose cancer has spread to the lymph nodes. Additionally, SCRT can help control stomach bleeding, a common issue in stomach cancer. Previous research suggests that this approach may offer better cancer control with potentially fewer side effects than traditional treatments. ^{2 4 6 7 8}

Who Is on the Research Team?

Patrick Grierson, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for patients with early stage gastric (stomach) cancer. Participants should be candidates for chemotherapy and surgical removal of the tumor. Specific eligibility criteria are not provided, but typically include factors like overall health status and absence of conditions that could interfere with treatment or skew results.

Inclusion Criteria

My blood tests show enough white blood cells, platelets, and my kidneys are working well.

I am 18 years old or older.

I agree to use birth control during the study.

Exclusion Criteria

My cancer is located at the junction of my stomach and esophagus.

I have had surgery, radiation, or chemotherapy for stomach or esophagus cancer.

A history of allergic reactions attributed to compounds of similar chemical or biologic composition to the SOC chemotherapy used in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Short Course Radiation Therapy

Participants receive short course radiation therapy as part of the neoadjuvant treatment

1-2 weeks

Neoadjuvant Chemotherapy

Participants receive 4 months of standard of care neoadjuvant chemotherapy

16 weeks

Surgery or Surveillance

Participants undergo gastrectomy if medically operable or surveillance if medically inoperable

Estimated to be 6 months for operable patients

Follow-up

Participants are monitored for complete response and safety after treatment

12 months for inoperable patients

What Are the Treatments Tested in This Trial?

Interventions

• Short course radiation therapy
• Standard of care neoadjuvant chemotherapy

Trial Overview The study tests adding short course radiation therapy to standard neoadjuvant chemotherapy before surgery in stomach cancer patients. The goal is to see if this Total Neoadjuvant Therapy increases complete response rates while reducing side effects compared to current treatments.

How Is the Trial Designed?

Group I: SCRT + SOC Neoadjuvant Chemotherapy Experimental Treatment 2 Interventions

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).

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12122511/

Gastric cancer radiation therapy: a bibliometric analysis of the ... The results indicated significant DFS improvement in lymph node-positive and intestinal-type GC patients with combined radiochemotherapy.

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/65/NCT04162665/Prot_SAP_000.pdf

Pre-operative Adaptive Short Course Radiation Therapy in ... Thus, adaptive radiation therapy may overcome traditional barriers of radiation delivery in gastric cancer and improve oncologic outcomes. Short ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.3_suppl.362

Phase I trial of short-course chemoradiotherapy followed ... After CXRT, 22 patients (92%) completed 2 months of chemotherapy, 1 patient (4%) with a microsatellite-high tumor completed immunotherapy, and 1 ...

4. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-021-01884-5

Efficacy of radiotherapy for gastric bleeding associated with ... RT was an effective modality for gastric bleeding control in gastric cancer, which can be achieved with a short course scheme with five fractions.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2452109423001094

Survival and Recurrence Patterns in Patients With Stomach ... Patients who received adjuvant CTRT after D2 dissection showed similar overall survival but significantly higher RFS than the CT-alone cohort.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39237045/

Phase 1 Trial: Neoadjuvant Therapy for Gastric Cancer Conclusion: Short-course CRT may be safely used as part of planned TNT for patients with potentially resectable gastric or gastroesophageal ...

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1513255/full

Gastric cancer radiation therapy: a bibliometric analysis of ... Results showed improved survival outcomes in the radiochemotherapy group (48.6 months vs. 24.0 months, P=0.003), with a higher R0 resection rate ...

8. redjournal.org redjournal.org/article/S0360-3016(24)03319-4/abstract

Phase 1 Trial of Total Neoadjuvant Therapy With Short ... Short-course CRT may be safely used as part of planned TNT for patients with potentially resectable gastric or gastroesophageal adenocarcinoma.