Clinical trial · Interventional
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
NCT03680586CI-TRIAL-00108385active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Mucosa-Associated Lymphoid Tissue Lymphoma | Gastric Mucosa-Associated Lymphoid Tissue Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Drug | Radiation Therapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (low-dose radiation therapy)
- description
- 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.
- interventionNames
- Drug: Radiation Therapy
Primary outcomes (1)
- measure
- Complete gastric response
- timeFrame
- Up to 1 year
- description
- The complete response rate at one year will be estimated along with 95% confidence intervals.
Secondary outcomes (6)
- measure
- Distant recurrence defined as disease progression outside of the stomach that was not present initially
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDGunther 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 38843856