Clinical Trial: Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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
Sponsor: Trans-Tasman Radiation Oncology Group (TROG)

Current Primary Outcome:

  • 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. ]
  • Complete response rate [ Time Frame: A final analysis at 10 years form the end of accrual. ]
  • Cancer-specific survival [ Time Frame: A final analysis at 10 years form the end of accrual. ]


Original Primary Outcome:

  • Freedom from locoregional progression (FFLRP) rate
  • Complete response rate
  • Cancer-specific survival


Current Secondary Outcome:

  • Overall survival [ Time Frame: A final analysis at 10 years form the end of accrual. ]
  • Progression free survival [ Time Frame: A final analysis at 10 years form the end of accrual. ]
  • Freedom from progression [ Time Frame: A final analysis at 10 years form the end of accrual. ]
  • 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. ]


Original Secondary Outcome:

  • Overall survival
  • Progression free survival
  • Freedom from progression
  • Acute and Late Toxicity rates


Information By: Trans-Tasman Radiation Oncology Group (TROG)

Dates:
Date Received: September 14, 2006
Date Started: July 2007
Date Completion: April 2019
Last Updated: January 23, 2017
Last Verified: January 2017