Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around
Principal Investigator
by Ann Raldow, M.D.

Description

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.

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.

Keywords

Gastric Cancer, SCRT, Stomach Neoplasms, Short course radiation therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCLA
    Los Angeles California 90095 United States
  • Washington University School of Medicine
    Saint Louis Missouri 63110 United States
  • Moffitt Cancer Center
    Tampa Florida 33612 United States
  • Dana Farber Cancer Institute
    Boston Massachusetts 02215 United States

Lead Scientist at UCLA

  • Ann Raldow, M.D.
    Associate Professor-in-residence, Radiation Oncology, Medicine. Authored (or co-authored) 115 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Washington University School of Medicine
ID
NCT07101666
Phase
Phase 2 Stomach Cancer Research Study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated