Trial record 5 of 5 for:    "Gastric lymphoma"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154440
Recruitment Status : Unknown
Verified March 2007 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : March 26, 2007
Information provided by:
Technische Universität Dresden

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 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.

Condition or disease Intervention/treatment Phase
Lymphoma Lymphoma, Non-Hodgkin Drug: proton pump inhibitor Drug: clarithromycin Drug: amoxicillin Drug: metronidazole Procedure: radiation therapy Phase 3

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 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Low-Grade Gastric Non-Hodgkin‘s Lymphoma of Mucosa-Associated Lymphoid Tissue (MALT) Type Stages IE & II1E (HELYX-Study)
Study Start Date : November 2001
Estimated Study Completion Date : October 2013

Primary Outcome Measures :
  1. remission status after eradication therapy 3-monthly
  2. continuous complete remission (CCR) during follow-up
  3. remission status after radiation therapy (36 Gy vs 25.2 Gy)
  4. continuous complete remission after radiation therapy during follow-up

Secondary Outcome Measures :
  1. endoscopic controls every 3 months during the first year
  2. endoscopic controls twice yearly in the second year after CR
  3. complete tumor staging once yearly
  4. relapse after therapy after each intervention

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00154440

Contact: Andrea Morgner-Miehlke, MD, PhD +49351458 ext 2986
Contact: Renate Schmelz, MD +49351458 ext 4702/2986

Institute for Pathology Recruiting
Bayreuth, Bavaria, Germany, 95445
Contact: Manfred Stolte, MD, PhD    +49921400 ext 5600   
Contact: Michael Vieth, MD, PhD    +49921400 ext 5602   
Sub-Investigator: Michael Vieth, MD, PhD         
Med. Dept. I, Gastroenterology Recruiting
Dresden, Saxonia, Germany, 01307
Contact: Gerhard Ehninger, MD, PhD    +49251458 ext 4190   
Contact: Stephan Miehlke, MD, PhD    +49351458 ext 5645   
Sub-Investigator: Stephan Miehlke, MD, PhD         
Dept. for Radiation Therapy & Radiooncology, University Hospital Recruiting
Germany, Saxonia, Germany, 01307
Contact: Thomas Herrmann, MD, PhD    +49351458 ext 3373   
Contact: Monique Dawel, MD    +49351458 ext 3373   
Sub-Investigator: Monique Dawel, MD         
Sponsors and Collaborators
Technische Universität Dresden
Principal Investigator: Andrea Morgner-Miehlke, MD, PhD Med. Dept. I, University Hospital, Technical University Dresden


Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00154440     History of Changes
Other Study ID Numbers: HELYX Study
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 26, 2007
Last Verified: March 2007

Keywords provided by Technische Universität Dresden:
primary gastric MALT lymphoma
Helicobacter pylori
eradication therapy
marginal zone B-cell lymphoma
Mucosa-associated Lymphoid Tissue
B-cell Non-Hodgkin's Lymphoma of the stomach
primary gastric lymphoma

Additional relevant MeSH terms:
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors