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

September 8, 2005
March 23, 2007
November 2001
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00154440 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Helicobacter – Lymphoma – Radiation Part I: Eradication, Part II: Radiation
Treatment of Low-Grade Gastric Non-Hodgkin‘s Lymphoma of Mucosa-Associated Lymphoid Tissue (MALT) Type Stages IE & II1E (HELYX-Study)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Drug: proton pump inhibitor
  • Drug: clarithromycin
  • Drug: amoxicillin
  • Drug: metronidazole
  • Procedure: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
October 2013
Not Provided

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
Both
18 Years to 75 Years
No
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
Germany
 
NCT00154440
HELYX Study
Yes
Not Provided
Technische Universität Dresden
Not Provided
Principal Investigator: Andrea Morgner-Miehlke, MD, PhD Med. Dept. I, University Hospital, Technical University Dresden
Technische Universität Dresden
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP