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Non-gastric Marginal Zone LymphomaPhase 2NCT00377195

Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma

A Phase 2 study testing Involved Field Radiotherapy in people with Non-gastric Marginal Zone Lymphoma, run by Trans Tasman Radiation Oncology Group at 5 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-gastric Marginal Zone Lymphoma
What is being tested?
Involved Field Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
5 sitesAustralia
Study dates
8 Jul 2007to Apr 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Calvary Mater Newcastle

    Newcastle, New South Wales

Other trials in Australia

About this study

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
Read the 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.

Being tested
Involved Field Radiotherapy
Keywords
Marginal Zone Lymphoma, Involved field radiotherapy, H. pylori
Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Involved Field RadiotherapyRadiation

    Also called Radiation

    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.

Study groups in NCT00377195
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Radiation: Involved Field Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from locoregional progression (FFLRP) rate

    Measured: 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.

  2. Complete response rate

    Measured: A final analysis at 10 years form the end of accrual.

  3. Cancer-specific survival

    Measured: A final analysis at 10 years form the end of accrual.

Secondary outcomes (4)

  1. Overall survival

    Measured: A final analysis at 10 years form the end of accrual.

  2. Progression free survival

    Measured: A final analysis at 10 years form the end of accrual.

  3. Freedom from progression

    Measured: A final analysis at 10 years form the end of accrual.

  4. Acute and Late Toxicity rates

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2006 (estimated)
  2. Study start8 Jul 2007
  3. Primary completion24 Apr 2017
  4. Study completionApr 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00377195
Sponsor's protocol ID
TROG 05.02
Status last verified
Feb 2018
First submitted
14 Sep 2006
Last updated
28 Feb 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Involved Field Radiotherapy in people with Non-gastric Marginal Zone Lymphoma, run by Trans Tasman Radiation Oncology Group at 5 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00377195.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.

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