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Radiation Therapy

Ultra Low-Dose Radiation Therapy for Gastric Lymphoma

Q: Is enrollment for this experiment currently open?

<p>Per the information found on clinicaltrials.gov, this research initiative is currently seeking participants. This trial was initially published in February of 2019 and last modified in September 2022.</p>

Q: To what extent is enrollment available for this clinical examination?

<p>Affirmative. According to clinicaltrials.gov, this research study has been actively recruiting since its initial posting on February 4th 2019 and was last modified on September 22nd 2022. 24 volunteers are being sought from one primary location.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete gastric response

Secondary outcome measures

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,777 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,621 Total Patients Enrolled

Jillian GuntherPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment currently open?

"Per the information found on clinicaltrials.gov, this research initiative is currently seeking participants. This trial was initially published in February of 2019 and last modified in September 2022."

Answered by AI

To what extent is enrollment available for this clinical examination?

"Affirmative. According to clinicaltrials.gov, this research study has been actively recruiting since its initial posting on February 4th 2019 and was last modified on September 22nd 2022. 24 volunteers are being sought from one primary location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ultra Low-Dose Radiation Therapy in Treating Patients With Stage I-IV Stomach MALT Lymphoma

2019. "Ultra Low-Dose Radiation Therapy in Treating Patients With Stage I-IV Stomach MALT Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03680586.

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