Ultra Low-Dose Radiation Therapy in Treating Patients With Stage I-IV Stomach MALT Lymphoma
Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Gastric MALT Lymphoma
2 other identifiers
interventional
25
1 country
1
Brief Summary
This trial studies how well ultra low-dose radiation therapy works in treating patients with stage I-IV stomach mucosa-associated lymphoid tissue (MALT) lymphoma. Ultra low-dose radiation therapy may be able to kill tumor cells and shrink tumors while having fewer side effects in patients with MALT lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Feb 2019
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
September 21, 2018
CompletedStudy Start
First participant enrolled
February 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
April 15, 2026
April 1, 2026
9.2 years
September 20, 2018
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Complete gastric response
The complete response rate at one year will be estimated along with 95% confidence intervals.
Up to 1 year
Secondary Outcomes (6)
Distant recurrence defined as disease progression outside of the stomach that was not present initially
Up to 1 year
Incidence of acute gastrointestinal toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03
Up to 1 year
Incidence of chronic gastrointestinal toxicity graded according to CTCAE v. 4.03
Up to 1 year
Time to local gastric event
Up to 1 year
Time to distant event
Up to 1 year
- +1 more secondary outcomes
Study Arms (1)
Treatment (low-dose radiation therapy)
EXPERIMENTALPatients 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.
Interventions
Undergo ultra low-dose radiation
Eligibility Criteria
You may qualify if:
- Patients 18 years or older with stage I-IV MALT lymphoma involving the stomach. Other low grade lymphomas including follicular grade I/II and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible
- Patients must have biopsy-proven disease within the stomach. Patients with clinical and/or radiographic masses will have dimensions noted prior to therapy
- Patients must have H. pylori testing which is negative within 6 months prior to treatment
- Female patients of childbearing potential must have a negative serum pregnancy test (human chorionic gonadotropin \[hCG\]) within 2 weeks of protocol entry
- Planned 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
- Patients must have the ability to give informed consent
- Necessary treatment with antibiotics for reasons unrelated to gastric lymphoma is permitted however the timing and nature of the treatment will be recorded
You may not qualify if:
- 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
- Patients with bulky tumors \> 10 cm in any dimension
- Patients with a history of prior radiation to the stomach if re-treatment would exceed known gastric or surrounding critical structure (e.g., bowel, spinal cord) tolerance
- Patients who are pregnant
- Patients with scleroderma are ineligible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Gunther JR, Xu J, Bhutani MS, Strati P, Fang PQ, Wu SY, Dabaja BS, Dong W, Bhosale PR, Flowers CR, Nair R, Malpica Castillo L, Fayad L, Iyer SP, Parmer S, Wang M, Lee HJ, Samaniego F, Westin J, Ahmed S, Nze CC, Jain P, Neelapu SS, Rodriguez MA, Chihara D, Nastoupil LJ, Pinnix CC. Response-adapted ultra-low-dose 4 Gy radiation as definitive therapy of gastric MALT lymphoma: a single-centre, pilot trial. Lancet Haematol. 2024 Jul;11(7):e521-e529. doi: 10.1016/S2352-3026(24)00133-9. Epub 2024 Jun 3.
PMID: 38843856DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jillian Gunther
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2018
First Posted
September 21, 2018
Study Start
February 4, 2019
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
April 30, 2028
Last Updated
April 15, 2026
Record last verified: 2026-04