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Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma

NCT00377195 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2018-02-28

No results posted yet for this study

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

Conditions

  • Non-gastric Marginal Zone Lymphoma

Interventions

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.

Sponsors & Collaborators

  • Australasian Leukaemia and Lymphoma Group

    collaborator OTHER

  • Peter MacCallum Cancer Centre, Australia

    collaborator OTHER

  • Trans Tasman Radiation Oncology Group

    lead OTHER

Principal Investigators

  • Michael MacManus · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-08
Primary Completion
2017-04-24
Completion
2019-04-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00377195 on ClinicalTrials.gov