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Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma

Primary Purpose

Non-gastric Marginal Zone Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

Involved Field Radiotherapy

About this trial

This is an interventional treatment trial for Non-gastric Marginal Zone Lymphoma focused on measuring Marginal Zone Lymphoma, Involved field radiotherapy, H. pylori

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Royal Prince Alfred Hospital
Calvary Mater Newcastle
Royal Brisbane and Women's Hospital
Royal Adelaide Hospital
Peter MacCallum Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Freedom from locoregional progression (FFLRP) rate

Complete response rate

Cancer-specific survival

Secondary Outcome Measures

Overall survival

Progression free survival

Freedom from progression

Acute and Late Toxicity rates

Full Information

NCT ID

NCT00377195

First Posted

September 14, 2006

Last Updated

February 27, 2018

Sponsor

Trans Tasman Radiation Oncology Group

Collaborators

Australasian Leukaemia and Lymphoma Group, Peter MacCallum Cancer Centre, Australia

1. Study Identification

Unique Protocol Identification Number

NCT00377195

Brief Title

Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 8, 2007 (Actual)

Primary Completion Date

April 24, 2017 (Actual)

Study Completion Date

April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Trans Tasman Radiation Oncology Group

Collaborators

Australasian Leukaemia and Lymphoma Group, Peter MacCallum Cancer Centre, Australia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-gastric Marginal Zone Lymphoma

Keywords

Marginal Zone Lymphoma, Involved field radiotherapy, H. pylori

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Involved Field Radiotherapy

Other Intervention Name(s)

Radiation

Intervention Description

The prescribed dose will be 30 Gy in 15-20 fractions, unless the orbit is to be treated, in which case the dose will be 24 Gy in 1.5 to 2 Gy fractions. Daily fractions of 1.5-2.0 Gy will be employed. Treatment will be given 5 days per week with the planned duration of treatment not exceeding 28 days.

Primary Outcome Measure Information:

Title

Freedom from locoregional progression (FFLRP) rate

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.

Title

Complete response rate

Time Frame