Non-gastric Marginal Zone Lymphoma Clinical Trial
Official title:
A Prospective Single Arm Trial of Involved Field Radiotherapy Alone for Stage I-II Low Grade Non-gastric Marginal Zone Lymphoma
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
Aims of the study :
- To conduct the first multicentre prospective trial of radiotherapy (RT) in stage I-II
Marginal Zone Lymphoma (MZL)
- To prospectively identify causal factors for MZL, including infection and inflammatory
disease
This study will be the first large trial of any form of therapy for stage I-II, non-gastric
marginal zone lymphoma. There is an enormous deficit in the literature with respect to this
fascinating but relatively recently-recognised entity. MZL is commonly associated with
underlying inflammatory or infective disorders and it is clear, at least in some cases with
infection by organisms called Helicobacter pylori and Chlamydia psitacci, that the
inflammatory condition can actually cause the lymphoma. The role of H. pylori infection has
not been well studied in non gastric MZL in large prospective studies, despite anecdotal
reports of regression of non gastric MZL after H. pylori eradication. There have been reports
of responses to doxycycline (antibacterial) therapy in patients with evidence of chlamydial
infection (C. psitacci) in MZL of the tissues around the eye. This association has not been
well studied in any large prospective study and no long-term data for doxycycline therapy
exist. Management of stage I-II MZL is variable and often ad-hoc in Australia, despite
significant retrospective evidence to support radiotherapy (RT) as the curative treatment
modality of choice. In this TROG/ALLG joint study, 100 patients will be recruited over 5
years. All patients will undergo breath tests or endoscopy to detect H. pylori infection.
Ocular MZL specimens will be sent to Italy to test for C. psitacci. Patients will receive
highly standardised treatment with RT. This study will definitively document the efficacy and
safety of RT in stage I and II non-gastric MZL and will include patients with stage IV
disease limited to paired-organs, as this disease shows a tendency to home in exclusively on
particular organs, such as salivary glands.
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