Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003151
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
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:
RATIONALE Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma
PURPOSE Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated
PURPOSE Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated
Detailed Description:
OBJECTIVES I Determine the rate of eradication of Helicobacter pylori using omeprazole colloidal bismuth subcitrate tetracycline and metronidazole in patients with low grade gastric lymphoma II Determine the macroscopicendoscopic and microscopic healingremission rate after eradication of Helicobacter pylori in this patient population III Determine the natural history of low grade gastric lymphoma after eradication of Helicobacter pylori
OUTLINE This is a nonrandomized open label multicenter study Patients receive oral omeprazole bid on days 1-10 oral bismuth subcitrate and oral tetracycline qid on days 4-10 and oral metronidazole tid on days 4-10 Patients are evaluated at 8 weeks Patients who experience complete remission and are H pylori negative proceed to follow up Patients with complete remission or no change but who are H pylori positive proceed to a second course of therapy with the previous schedule or with omeprazole bid amoxicillin qid and clarithromycin tid for 14 days Patients who experience no change but are H pylori negative are followed at 6 and 9 months and restaged Patients are followed at 6 9 12 18 and 24 months then annually thereafter
PROJECTED ACCRUAL Approximately 60-96 patients will be accrued for this study
OUTLINE This is a nonrandomized open label multicenter study Patients receive oral omeprazole bid on days 1-10 oral bismuth subcitrate and oral tetracycline qid on days 4-10 and oral metronidazole tid on days 4-10 Patients are evaluated at 8 weeks Patients who experience complete remission and are H pylori negative proceed to follow up Patients with complete remission or no change but who are H pylori positive proceed to a second course of therapy with the previous schedule or with omeprazole bid amoxicillin qid and clarithromycin tid for 14 days Patients who experience no change but are H pylori negative are followed at 6 and 9 months and restaged Patients are followed at 6 9 12 18 and 24 months then annually thereafter
PROJECTED ACCRUAL Approximately 60-96 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HOVON-33 | None | None | None |
| EORTC-20961 | None | None | None |
| CRC-EORTC-20961 | None | None | None |