A Prospective Single Arm Trial of Involved Field Radiotherapy Alone for Stage I-II Low Grade Non-gastric Marginal Zone Lymphoma
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Freedom from locoregional progression (FFLRP) rate
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.
Peter MacCallum Cancer Centre, Australia
Australia: Human Research Ethics Committee