Status:
UNKNOWN
Helicobacter - Lymphoma - Radiation Part I: Eradication, Part II: Radiation
Lead Sponsor:
Technische Universität Dresden
Conditions:
Lymphoma
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
End Date :
October 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00154440
Start Date
November 1 2001
End Date
October 1 2013
Last Update
March 26 2007
Active Locations (3)
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1
Institute for Pathology
Bayreuth, Bavaria, Germany, 95445
2
Med. Dept. I, Gastroenterology
Dresden, Saxony, Germany, 01307
3
Dept. for Radiation Therapy & Radiooncology, University Hospital
Germany, Saxony, Germany, 01307