Study Summary
This trial is testing how well ultra low-dose radiation therapy works to treat patients with MALT lymphoma.
Eligible Conditions
- Gastric Mucosa-Associated Lymphoid Tissue Lymphoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Up to 1 year
Up to 1 year
Complete gastric response
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
Time to distant event
Time to local gastric event
Tumor response
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment (low-dose radiation therapy)
1 of 1
Experimental Treatment
24 Total Participants · 1 Treatment Group
Primary Treatment: Radiation Therapy · No Placebo Group · Phase < 1
Treatment (low-dose radiation therapy)
Drug
Experimental Group · 1 Intervention: Radiation Therapy · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2005
Completed Phase 3
~7010
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,808 Previous Clinical Trials
1,790,467 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,091 Previous Clinical Trials
41,142,670 Total Patients Enrolled
Jillian GuntherPrincipal InvestigatorM.D. Anderson Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a minimum platelet count of at least 100,000 per microlitre of blood, which is slightly below the typical healthy range
You must have a negative H
You are female and of childbearing potential.
Patients must have biopsy-proven disease within the stomach.
Systemic therapy prior to, during, or after gastric radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of systemic therapy.
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Conditions
Cancer Related
Treatments