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Radiation Therapy

Ultra Low-Dose Radiation Therapy for Gastric Lymphoma

Phase < 1

Waitlist Available

Led By Jillian Gunther

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients 18 years or older with stage I-IV MALT lymphoma involving the stomach

Patients must have biopsy-proven disease within the stomach. Patients with clinical and/or radiographic masses will have dimensions noted prior to therapy

Must not have

Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma

Patients with other histologic subtypes of low grade lymphoma (other than MALT) including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or follicular lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well ultra low-dose radiation therapy works to treat patients with MALT lymphoma.

Who is the study for?

This trial is for adults with stage I-IV stomach MALT lymphoma, who have tested negative for H. pylori within 6 months and are not pregnant. It's open to those who haven't had prior radiation that would exceed safe levels upon re-treatment and don't have aggressive B cell lymphoma or bulky tumors over 10 cm.

What is being tested?

The study is testing ultra low-dose radiation therapy on patients with stomach MALT lymphoma to see if it can effectively shrink tumors and kill cancer cells while minimizing side effects compared to traditional doses.

What are the potential side effects?

While the aim is fewer side effects due to the ultra low dose, potential risks may include skin irritation at the treatment site, mild fatigue, nausea, or more rarely changes in blood counts.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older with a specific type of stomach cancer.

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My stomach cancer has been confirmed with a biopsy.

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I am a woman who can have children and have a recent negative pregnancy test.

Exclusion Criteria

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

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My condition is aggressive B cell lymphoma, such as DLBCL or grade 3 follicular lymphoma.

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I have a low-grade lymphoma, but it's not MALT.

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My tumor is larger than 10 cm in size.

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I've had radiation to my stomach and cannot have more without risking damage to nearby organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year 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 gastric response

Secondary study objectives

Distant recurrence defined as disease progression outside of the stomach that was not present initially

Incidence of acute gastrointestinal toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03

Incidence of chronic gastrointestinal toxicity graded according to CTCAE v. 4.03

+3 more

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: Treatment (low-dose radiation therapy)Experimental Treatment1 Intervention

Patients undergo low-dose radiation therapy over 2 fractions for 2 consecutive days in the absence of disease progression or unacceptable toxicity. Patients with stable or progressive disease at 12-16 weeks post-treatment, or persistent disease at 1 year may undergo higher-dose radiation therapy at the discretion of treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 7Eligibility criteria met