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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00154440
First received: September 8, 2005
Last updated: March 23, 2007
Last verified: March 2007
  Purpose

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 Intervention Phase
Lymphoma
Lymphoma, Non-Hodgkin
Drug: proton pump inhibitor
Drug: clarithromycin
Drug: amoxicillin
Drug: metronidazole
Procedure: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

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

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

Estimated Enrollment: 200
Study Start Date: November 2001
Estimated Study Completion Date: October 2013
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154440

Contacts
Contact: Andrea Morgner-Miehlke, MD, PhD +49351458 ext 2986 andrea.morgner-miehlke@uniklinikum-dresden.de
Contact: Renate Schmelz, MD +49351458 ext 4702/2986 renate.schmelz@uniklinikum-dresden.de

Locations
Germany
Institute for Pathology Recruiting
Bayreuth, Bavaria, Germany, 95445
Contact: Manfred Stolte, MD, PhD    +49921400 ext 5600    pathologie.klinikum@bnbt.de   
Contact: Michael Vieth, MD, PhD    +49921400 ext 5602    Vieth.LKPathol@uni-bayreuth.de   
Sub-Investigator: Michael Vieth, MD, PhD         
Med. Dept. I, Gastroenterology Recruiting
Dresden, Saxonia, Germany, 01307
Contact: Gerhard Ehninger, MD, PhD    +49251458 ext 4190    gerhard.ehninger@uniklinikum-dresden.de   
Contact: Stephan Miehlke, MD, PhD    +49351458 ext 5645    stephan.miehlke@uniklinikum-dresden.de   
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    thomas.herrmann@uniklinikum-dresden.de   
Contact: Monique Dawel, MD    +49351458 ext 3373    monique.dawel@uniklinikum-dresden.de   
Sub-Investigator: Monique Dawel, MD         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Andrea Morgner-Miehlke, MD, PhD Med. Dept. I, University Hospital, Technical University Dresden
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00154440     History of Changes
Other Study ID Numbers: HELYX Study
Study First Received: September 8, 2005
Last Updated: March 23, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
primary gastric MALT lymphoma
Helicobacter pylori
eradication therapy
radiation
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
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Clarithromycin
Metronidazole
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014