Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Short course radiation therapy
  • Standard of care neoadjuvant chemotherapy

Treatment groups

20 Participants
are divided into 1 treatment group