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

NCT00154440 | Unknown Phase 3 DMC

• 1 other identifier: HELYX Study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Lymphoma; Lymphoma, Non-Hodgkin

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Interventions

proton pump inhibitor DRUG

clarithromycin DRUG

amoxicillin DRUG

metronidazole DRUG

radiation therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (3)

Institute for Pathology

Bayreuth, Bavaria, 95445, Germany

RECRUITING

Med. Dept. I, Gastroenterology

Dresden, Saxony, 01307, Germany

RECRUITING

Dept. for Radiation Therapy & Radiooncology, University Hospital

Germany, Saxony, 01307, Germany

RECRUITING

Related Publications (10)

• Akagi T, Motegi M, Tamura A, Suzuki R, Hosokawa Y, Suzuki H, Ota H, Nakamura S, Morishima Y, Taniwaki M, Seto M. A novel gene, MALT1 at 18q21, is involved in t(11;18) (q21;q21) found in low-grade B-cell lymphoma of mucosa-associated lymphoid tissue. Oncogene. 1999 Oct 14;18(42):5785-94. doi: 10.1038/sj.onc.1203018.

  PMID: 10523859 BACKGROUND

• Alpen B, Neubauer A, Dierlamm J, Marynen P, Thiede C, Bayerdorfer E, Stolte M. Translocation t(11;18) absent in early gastric marginal zone B-cell lymphoma of MALT type responding to eradication of Helicobacter pylori infection. Blood. 2000 Jun 15;95(12):4014-5. No abstract available.

  PMID: 10939796 BACKGROUND

• Bayerdorffer E, Neubauer A, Rudolph B, Thiede C, Lehn N, Eidt S, Stolte M. Regression of primary gastric lymphoma of mucosa-associated lymphoid tissue type after cure of Helicobacter pylori infection. MALT Lymphoma Study Group. Lancet. 1995 Jun 24;345(8965):1591-4. doi: 10.1016/s0140-6736(95)90113-2.

  PMID: 7783535 BACKGROUND

• Hussell T, Isaacson PG, Crabtree JE, Spencer J. The response of cells from low-grade B-cell gastric lymphomas of mucosa-associated lymphoid tissue to Helicobacter pylori. Lancet. 1993 Sep 4;342(8871):571-4. doi: 10.1016/0140-6736(93)91408-e.

  PMID: 8102718 BACKGROUND

• Liu H, Ruskon-Fourmestraux A, Lavergne-Slove A, Ye H, Molina T, Bouhnik Y, Hamoudi RA, Diss TC, Dogan A, Megraud F, Rambaud JC, Du MQ, Isaacson PG. Resistance of t(11;18) positive gastric mucosa-associated lymphoid tissue lymphoma to Helicobacter pylori eradication therapy. Lancet. 2001 Jan 6;357(9249):39-40. doi: 10.1016/S0140-6736(00)03571-6.

  PMID: 11197361 BACKGROUND

• Neubauer A, Thiede C, Morgner A, Alpen B, Ritter M, Neubauer B, Wundisch T, Ehninger G, Stolte M, Bayerdorffer E. Cure of Helicobacter pylori infection and duration of remission of low-grade gastric mucosa-associated lymphoid tissue lymphoma. J Natl Cancer Inst. 1997 Sep 17;89(18):1350-5. doi: 10.1093/jnci/89.18.1350.

  PMID: 9308704 BACKGROUND

• Schechter NR, Portlock CS, Yahalom J. Treatment of mucosa-associated lymphoid tissue lymphoma of the stomach with radiation alone. J Clin Oncol. 1998 May;16(5):1916-21. doi: 10.1200/JCO.1998.16.5.1916.

  PMID: 9586910 BACKGROUND

• Thiede C, Morgner A, Alpen B, Wundisch T, Herrmann J, Ritter M, Ehninger G, Stolte M, Bayerdorffer E, Neubauer A. What role does Helicobacter pylori eradication play in gastric MALT and gastric MALT lymphoma? Gastroenterology. 1997 Dec;113(6 Suppl):S61-4. doi: 10.1016/s0016-5085(97)80014-5.

  PMID: 9394762 BACKGROUND

• Ruskone-Fourmestraux A, Dragosics B, Morgner A, Wotherspoon A, De Jong D. Paris staging system for primary gastrointestinal lymphomas. Gut. 2003 Jun;52(6):912-3. doi: 10.1136/gut.52.6.912. No abstract available.

  PMID: 12740354 BACKGROUND

• Schmelz R, Miehlke S, Thiede C, Brueckner S, Dawel M, Kuhn M, Ruskone-Formestraux A, Stolte M, Jentsch C, Hampe J, Morgner A. Sequential H. pylori eradication and radiation therapy with reduced dose compared to standard dose for gastric MALT lymphoma stages IE & II1E: a prospective randomized trial. J Gastroenterol. 2019 May;54(5):388-395. doi: 10.1007/s00535-018-1517-4. Epub 2018 Oct 16.

  PMID: 30327875 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone; Familial primary gastric lymphoma

Interventions

Proton Pump Inhibitors; Clarithromycin; Amoxicillin; Metronidazole; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• Andrea Morgner-Miehlke, MD, PhD

  Med. Dept. I, University Hospital, Technical University Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Morgner-Miehlke, MD, PhD

CONTACT

+49351458; andrea.morgner-miehlke@uniklinikum-dresden.de

Renate Schmelz, MD

CONTACT

+49351458; renate.schmelz@uniklinikum-dresden.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: November 1, 2001
• Study Completion: October 1, 2013
• Last Updated: March 26, 2007

Record last verified: 2007-03

Locations

DE (3)