Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Trans-Tasman Radiation Oncology Group (TROG)
Sponsor:
Collaborators:
Australasian Leukaemia and Lymphoma Group
Peter MacCallum Cancer Centre, Australia
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00377195
First received: September 14, 2006
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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

Condition Intervention Phase
Non-gastric Marginal Zone Lymphoma
Radiation: Involved Field Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Single Arm Trial of Involved Field Radiotherapy Alone for Stage I-II Low Grade Non-gastric Marginal Zone Lymphoma

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Complete response rate [ Time Frame: A final analysis at 10 years form the end of accrual. ] [ Designated as safety issue: No ]
  • Cancer-specific survival [ Time Frame: A final analysis at 10 years form the end of accrual. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: A final analysis at 10 years form the end of accrual. ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: A final analysis at 10 years form the end of accrual. ] [ Designated as safety issue: No ]
  • Freedom from progression [ Time Frame: A final analysis at 10 years form the end of accrual. ] [ Designated as safety issue: No ]
  • Acute and Late Toxicity rates [ 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: July 2007
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Radiation: Involved Field Radiotherapy

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.

Other Name: Radiation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377195

Contacts
Contact: Michael MacManus +61 03 9656 1111 Michael.Macmanus@petermac.org

Locations
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia
Contact: Angela Hong         
Principal Investigator: Angela Hong         
Calvary Mater Newcastle Recruiting
Newcastle, New South Wales, Australia
Contact: Peter O'Brien         
Principal Investigator: Peter O'Brien         
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Brisbane, Queensland, Australia
Principal Investigator: Garry Pratt         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia
Contact: Daniel Roos         
Principal Investigator: Daniel Roos         
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3002
Contact: Michael MacManus         
Principal Investigator: Michael MacManus         
Principal Investigator: John Seymour         
Canada
Princess Margaret Hospital Recruiting
Toronto, Canada
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Australasian Leukaemia and Lymphoma Group
Peter MacCallum Cancer Centre, Australia
Investigators
Study Chair: Michael MacManus Peter MacCallum Cancer Centre, Australia
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00377195     History of Changes
Other Study ID Numbers: TROG 05.02
Study First Received: September 14, 2006
Last Updated: July 31, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Marginal Zone Lymphoma
Involved field radiotherapy
H. pylori

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on September 14, 2014