Clinical trial · Interventional
Radiation Therapy Alone for the Treatment of Stage 1 and 2 Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma
Radiation Therapy Alone for Stage 1 and 2 MALT (Mucosa-Associated Lymphoid Tissue) Lymphoma
NCT04465162CI-TRIAL-00056836completedPhase 2Results postedClinicalTrials.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 the side effects of radiation therapy used alone, and if it can achieve a high cure rate in the treatment of patients with MALT lymphoma. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors. This treatment may improve the patient's lymphoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | — | UNRESOLVED | — |
| Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | — | UNRESOLVED | — |
| Extranodal Marginal Zone Lymphoma | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiation therapy)
- description
- Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks.
- interventionNames
- Other: Radiation Therapy
Primary outcomes (1)
- measure
- Relapse-free Survival (RFS)
- timeFrame
- Through study completion, up to 10 years
- description
- RFS was defined as the time in months from the date of study entry until the last follow-up or death, with all deaths censored. Kaplan-Meier curves were estimated for the survival distributions.
Secondary outcomes (3)
- measure
- Median Progression Free Survival (PFS)
- timeFrame
- 17.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed stage 1 and 2 MALT lymphoma are eligible for this study * Patients with Helicobacter (H.) pylori positive gastric MALT lymphoma are recommended to have treatments with antibiotics prior to enrollment to this protocol * Patients who failed other treatment modalities (e.g. chemotherapy, antibiotics therapy etc) are also eligible as far as they never had stage 3 or 4 disease during the course of the disease or disease progression to the opposite side of the diaphragm (as the time course of the response to antibiotic therapy can be very variable among patients, sometimes requiring more than one year for complete response, failure to antibiotic therapy can be very variable among patients, sometimes requiring more than one year for complete response, failure to antibiotic treatment will be defined as no response or progression of the disease documented by endoscopy and biopsy) * Patients who have had stage 4 diseases due to bilateral parotid gland or ocular/ocular adnexal involvement or due to multiple sites within Waldeyer's ring will still be eligible Exclusion Criteria: * Patients who had previous radiation dose to the site of the current primary disease which would lead to violation of known radiation tolerance limit of that particular site if treated again * Patients with MALT lymphoma of the skin whose lesions are separated by more than 5 cm will be ineligible * Previous or concurrent malignancy in any form would not be an exclusion criterion. However, patients who receive chemotherapy for concurrent malignancy will be excluded from statistical analysis * Low blood cell counts would not be exclusion criteria as far as the patient is willing to accept supportive measures such as transfusions, filgrastim and epoetin
References
Publications (1)
- DERIVEDFang P, Gunther JR, Pinnix CC, Dong W, Strati P, Nastoupil LJ, Steiner RE, Ahmed S, Damron EP, Fowler N, Nair R, Westin JR, Neelapu S, Ha CS, Dabaja BS. A Prospective Trial of Radiation Therapy Efficacy and Toxicity for Localized Mucosa-associated Lymphoid Tissue (MALT) Lymphoma. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1414-1420. doi: 10.1016/j.ijrobp.2020.11.070. Epub 2020 Dec 10. PMID 33309978