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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year post radiation
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete pathologic response (pCR - primary and nodal) rate
Secondary outcome measures
Disease-free survival
Local control rate
Overall survival
+2 moreOther outcome measures
Average percent difference in coverage of planning target volume (PTV) by 95% isodose line
Average percentage difference in dose to nearby organs at risk (OARs) due to variation in OAR position
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
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,774 Total Patients Enrolled
Viewray Inc.Industry Sponsor
12 Previous Clinical Trials
1,053 Total Patients Enrolled
Hyun Kim, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
205 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor says I can have CAPOX chemotherapy.You are currently taking any experimental medications that are not approved by regulatory authorities.I can take care of myself but might not be able to do heavy physical work.I have had surgery on my esophagus or stomach.My cancer has spread, including to the lining of my abdomen.I am 19 years old or older.I have had surgery, radiation, or chemotherapy for stomach or esophagus cancer.I haven't had any cancer in the last 2 years that could affect my stomach cancer, except for cured or slow-growing ones.I can understand and am willing to sign a consent form.I do not have any uncontrolled illnesses like infections, diabetes, or heart issues.I have been newly diagnosed with a specific type of stomach cancer that has not spread too far.I have HIV but my CD4+ T-cell count is above 350 and I haven't had a major infection in the last year.My blood tests for bone marrow and organ function are normal.My cancer's size and spread were checked with specific scans.My cancer is located at the junction of my stomach and esophagus.I have fluid buildup in my abdomen.I am allergic to capecitabine, oxaliplatin, or similar drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-operative adaptive short course radiation therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently enrolling participants in this trial?
"This medical research project is currently enrolling participants, as indicated on clinicaltrials.gov; with the study first posted in February 2020 and most recently updated in March 2022."
Answered by AI
How many participants are involved in this research endeavor?
"Affirmative. Clinicaltrials.gov's information indicates that this medical trial is currently seeking participants, with the original post date of February 14th 2020 and last update on March 15th 2022. This research requires 36 patients from 1 site to be enrolled in the experiment."
Answered by AI
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