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Proton Beam Therapy

MR-Guided Radiation Therapy for Stomach Cancer

Phase 2

Recruiting

Led By Hyun Kim, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Medically eligible to receive CAPOX chemotherapy

ECOG performance status ≤ 2

Must not have

Prior surgery to the esophagus or stomach.

Metastatic disease, including gross peritoneal carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year post radiation

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new way of delivering radiation to stomach cancer patients, using MR-guided radiation therapy, may improve outcomes by being more accurate and using smaller treatment fields.

Who is the study for?

This trial is for adults over 19 with newly diagnosed gastric adenocarcinoma, specifically stages I-III without metastatic disease. Participants must have normal organ and bone marrow function, agree to use contraception, and not be pregnant or breastfeeding. They can't join if they've had prior treatments for gastric cancer, certain other cancers within the last two years, contraindications to MRI, or uncontrolled illnesses.

What is being tested?

The study tests MR-guided radiation therapy (MRgRT) alongside standard chemotherapy in treating stomach cancer. MRgRT aims to deliver more accurate radiation doses by accounting for daily organ motion and only targeting the tumor when it's correctly positioned.

What are the potential side effects?

Potential side effects may include those commonly associated with chemotherapy such as nausea, fatigue, blood disorders; and from radiation like skin irritation at the treatment site. The precise side effects of MRgRT are monitored due to its novel application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My doctor says I can have CAPOX chemotherapy.

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I can take care of myself but might not be able to do heavy physical work.

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I am 19 years old or older.

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I have been newly diagnosed with a specific type of stomach cancer that has not spread too far.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my esophagus or stomach.

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My cancer has spread, including to the lining of my abdomen.

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

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I do not have any uncontrolled illnesses like infections, diabetes, or heart issues.

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

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I have fluid buildup in my abdomen.

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I am allergic to capecitabine, oxaliplatin, or similar drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year post radiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year post radiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year post radiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete pathologic response (pCR - primary and nodal) rate

Secondary study objectives

Disease-free survival

Local control rate

Overall survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pre-operative adaptive short course radiation therapyExperimental Treatment2 Interventions

Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of care chemotherapy regimen

2017

Completed Phase 2

~50

0 / 11Eligibility criteria met