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Clinical Trial: Helicobacter - Lymphoma - Radiation Part I: Eradication, Part II: Radiation
Helicobacter – Lymphoma – Radiation Part I: Eradication, Part II: Radiation
This study is currently recruiting patients.
Verified by Dresden University of Technology August 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Lymphoma, Mucosa-Associated Lymphoid Tissue B-cell Non-Hodgkin''''y Lymphoma of the stomach, primary gastric | Drug: protonenpumpinhibitor, clarithromycin, amoxicillin or metronidazole Procedure: radiation therapy | Phase III |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title: Treatment of Low-Grade Gastric Non-Hodgkin‘s Lymphoma of Mucosa-Associated Lymphoid Tissue (MALT) Type Stages IE & II1E (HELYX-Study)
Secondary Outcomes: 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
Expected Total Enrollment: 200
Study start: November 2001; Expected completion: December 2013
Last follow-up: October 2013; Data entry closure: November 2013
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
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
Location and Contact Information
Renate Schmelz, MD +49351458 Ext. 4702/2986 renate.schmelz@uniklinikum-dresden.de
Germany, Bavaria
Institute for Pathology, Bayreuth, Bavaria, 95445, Germany; Recruiting
Michael Vieth, MD, PhD +49921400 Ext. 5602 Vieth.LKPathol@uni-bayreuth.de
Michael Vieth, MD, PhD, Sub-Investigator
Germany, Saxonia
Med. Dept. I, Gastroenterology, Dresden, Saxonia, 01307, Germany; Recruiting
Stephan Miehlke, MD, PhD +49351458 Ext. 5645 stephan.miehlke@uniklinikum-dresden.de
Stephan Miehlke, MD, PhD, Sub-Investigator
Dept. for Radiation Therapy & Radiooncology, University Hospital, Germany, Saxonia, 01307, Germany; Recruiting
Monique Dawel, MD +49351458 Ext. 3373 monique.dawel@uniklinikum-dresden.de
Monique Dawel, MD, Sub-Investigator
Andrea Morgner-Miehlke, MD, PhD, Principal Investigator, Med. Dept. I, University Hospital, Technical University Dresden
More Information
Publications
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.
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.
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.
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.
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.
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.
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.
Ruskone-Fourmestraux A, Dragosics B, Morgner A, Wotherspoon A, Dd Jong D. Paris staging system for primary gastrointestinal lymphomas. Gut. 2003 Jun;52(6):912-3. No abstract available.
Last Updated: September 9, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00154440
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
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