Helicobacter - Lymphoma - Radiation Part I: Eradication, Part II: Radiation
Status:
Unknown status
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
The first objective of this study is to confirm the results of complete remission of
low-grade gastric MALT lymphoma stage IE & II1E after H. pylori eradication on a larger
number of patients (HELYX Part I). If there is no response to the antibiotic therapy, the
role of radiotherapy on the course of gastric MALT lymphoma will be investigated as a
consecutive therapeutic option for patients that are H. pylori- negative, t(11;18)-positive
or failure candidates after eradication therapy. Furthermore, the method of radiation, and
the radiation dose will be investigated and standardized. HELYX PART II is therefore a
randomized equivalent study comparing the standard dose of 36Gy vs. a reduced dose of 25.2Gy
locoregional. Additional molecular genetic analysis will be performed to try to understand
pathogenetic mechanisms of lymphomagenesis.