Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154440
Status:
UNKNOWN
Last Update Posted:
2007-03-26
First Post:
2005-09-08
Brief Title:
Helicobacter - Lymphoma - Radiation Part I Eradication Part II Radiation
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Treatment of Low-Grade Gastric Non-Hodgkins Lymphoma of Mucosa-Associated Lymphoid Tissue MALT Type Stages IE II1E HELYX-Study
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 t1118-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 252Gy locoregional Additional molecular genetic analysis will be performed to try to understand pathogenetic mechanisms of lymphomagenesis
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 252Gy compared to the standard dose 36Gy will be investigated with the aim of non-inferiority of both doses
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 252Gy compared to the standard dose 36Gy will be investigated with the aim of non-inferiority of both doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None