Clinical trial · Interventional
Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma
A Prospective Single Arm Trial of Involved Field Radiotherapy Alone for Stage I-II Low Grade Non-gastric Marginal Zone Lymphoma
- 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 prospective study will test the following hypotheses in patients with stage I-II low grade marginal zone (MZ) lymphoma: * Involved Field Radiotherapy will produce a complete response rate of \> 90% * Radiotherapy will be associated with a locoregional progression of \< 20% after 10 years * Death from MZ lymphoma will occur in \< 40% of patients within 10 years of radiotherapy This study secondary objectives are: * To collect information on the prevalence of H. pylori in non-gastric MALT lymphoma * To estimate rates of acute and late toxicity of radiotherapy
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 |
|---|---|---|---|
| Non-gastric Marginal Zone Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Involved Field Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Radiation: Involved Field Radiotherapy
Primary outcomes (3)
- measure
- Freedom from locoregional progression (FFLRP) rate
- timeFrame
- There will be an interim analysis at the end of accual (approx 5 years), at 5 years from the end of accrual and a final analysis at 10 years form the end of accrual.
- measure
- Complete response rate
- timeFrame
- A final analysis at 10 years form the end of accrual.
- measure
- Cancer-specific survival
- timeFrame
- A final analysis at 10 years form the end of accrual.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients of at least 18 years old with histologically documented non-gastric marginal zone lymphoma. * Disease limited to stages I and II after adequate staging (see Appendix II), patients with stage IV with extranodal disease confined to paired organs (e.g. salivary glands) and including any local extension of this disease into adjacent tissues. Patients with involved lymph nodes on the same side of the diaphragm in addition to paired organ involvement are also eligible, provided all involved tumour sites, nodal and extranodal, can be irradiated to 30 Gy within the tolerance of the relevant normal tissues. If paired organ involvement was regarded as a single extranodal site (rather than 2 separate sites and hence stage IV), eligible patients would then be regarded as having stage IE or IIE disease. Patients with wider dissemination (bone marrow, liver etc) are ineligible. * Anticipated life expectancy \> 2 years * Given written informed consent * Been assessed by a radiation oncologist * Agree to undergo breath testing for H. pylori and/or oesophagogastroduodenoscopy to exclude active infection with helicobacter pylori * Must be available for long-term follow up Exclusion Criteria: * Splenic marginal zone lymphoma * Received previous locoregional radiotherapy * A medical contraindication to radiotherapy * Any previous or concurrent malignancy other than curatively treated non-melanoma skin cancer, level 1 malignant melanoma, or in situ cervical cancer, unless disease and treatment-free for 5 years * Such extensive involvement of the thorax that treatment with radiotherapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed * Suspected or confirmed pregnancy * Transformation to large cell lymphoma or other aggressive histology * Disease that is widely disseminated (bone marrow, liver etc)
References
Publications (0)
Data not yet available