Helicobacter - Lymphoma - Radiation Part I: Eradication, Part II: Radiation

• Status: Unknown status
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Amoxicillin; Clarithromycin; Metronidazole; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

• histologically diagnosed, primary gastric low-grade B-cell MALT lymphoma stages IE or II1E, Helicobacter pylori-positive (in histology, urease test , and serology) for inclusion into HELYX part I

• histologically diagnosed, primary gastric low-grade B-cell MALT lymphoma stages IE or II1E, Helicobacter pylori-negative (in histology, urease test, and serology) for inclusion into HELYX part II

• patients who achieved a study end point of HELYX I: partial remission or no change 12 months after successful antibiotic therapy for inclusion into HELYX part II,

• age > 18 and < 75 years

• Karnofsky-Index > 60%

• sufficient liver function, defined as bilirubin < 34µmol/l

• sufficient renal function, defined as creatinine < 133µmol/l

• written informed consent

• complete clinical tumor staging

Exclusion Criteria:

• primary gastric low-grade MALT lymphoma, stages >II1E or gastric high-grade lymphoma or other lymphoma entities of the stomach e.g. lymphoblastic lymphoma or Burkitt's lymphoma

• age < 18 and > 75 years

• Karnofsky-Index < 60%

• insufficient liver and renal function (see above)

• HIV-infection

• pregnancy or nursing