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A Prospective Single Arm Trial of Involved Field Radiotherapy Alone for Stage I-II Low Grade Non-gastric Marginal Zone Lymphoma

Phase 2
18 Years
Open (Enrolling)
Non-gastric Marginal Zone Lymphoma

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Trial Information

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.

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 limited to paired organ involvement (e.g., conjunctiva, parotid glands)
are also eligible

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Freedom from locoregional progression (FFLRP) rate

Outcome Time Frame:

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.

Safety Issue:


Principal Investigator

Michael MacManus

Investigator Role:

Study Chair

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia


Australia: Human Research Ethics Committee

Study ID:

TROG 05.02



Start Date:

July 2007

Completion Date:

July 2013

Related Keywords:

  • Non-gastric Marginal Zone Lymphoma
  • Marginal Zone Lymphoma
  • Involved field radiotherapy
  • H. pylori
  • Lymphoma
  • Lymphoma, B-Cell, Marginal Zone