Treatment of Low-Grade Gastric Non-Hodgkin‘s Lymphoma of Mucosa-Associated Lymphoid Tissue (MALT) Type Stages IE & II1E (HELYX-Study)
Experimental data have extended the knowledge of the mere association of gastric MALT
lymphoma and infection with Helicobacter pylori. If we summarise the reports to date on the
results of treatment of gastric low-grade MALT lymphoma in an early clinical stage (EI) by
H. pylori eradication we find a complete remission figure of 77% in more than 200 patients.
As a therapy with less side effects than radiation, surgery or chemotherapy and as a
stomach-conserving treatment, eradication of H. pylori in patients with low-grade gastric
MALT lymphoma in stages IE & II1E should be the treatment of the choice within clinical
trials since there are no long-term results available thus far. Besides, pretreatment
patient selection and careful follow-up with endoscopy, biopsies and clinical staging
including endoscopic ultrasonography is necessary. However, a five to ten year-follow-up
will be necessary before the definitive value of Helicobacter pylori eradication can be
established. Furthermore, since not all patients respond to this therapy research into the
pathogenetic mechanisms of lymphomagenesis is inevitable.
Approximately 20% of patients with antigen-positive, primary gastric low-grade MALT lymphoma
in stage I will not respond to eradication therapy. Hence, a consecutive salvage therapy
other than surgery is much needed. The aim of the second part of this study is to establish
radiation therapy as a salvage therapy. Furthermore, the effect of a reduced radiation dose
(25.2Gy) compared to the standard dose (36Gy) will be investigated with the aim of
non-inferiority of both doses.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
remission status after eradication therapy 3-monthly
Andrea Morgner-Miehlke, MD, PhD
Principal Investigator
Med. Dept. I, University Hospital, Technical University Dresden
Germany: Federal Institute for Drugs and Medical Devices
HELYX Study
NCT00154440
November 2001
October 2013
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