Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003617
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach
Sponsor:
Lymphoma Trials Office
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Protocol for a Randomised Trial of Observation Versus Chlorambucil After Anti-Helicobacter Therapy in Low Grade Gastric Lymphoma
Status:
UNKNOWN
Status Verified Date:
2009-04
Last Known Status:
ACTIVE_NOT_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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die It is not yet known whether chlorambucil is more effective than observation in treating low-grade lymphoma of the stomach
PURPOSE Randomized phase III trial to compare the effectiveness of chlorambucil with that of no further therapy following anti-Helicobacter therapy in treating patients with low-grade lymphoma of the stomach
PURPOSE Randomized phase III trial to compare the effectiveness of chlorambucil with that of no further therapy following anti-Helicobacter therapy in treating patients with low-grade lymphoma of the stomach
Detailed Description:
OBJECTIVES I Determine the efficacy and response rate of triple antibiotic therapy for Helicobacter pylori in the healing of lesions in patients with low grade gastric lymphoma II Assess the efficacy of chlorambucil in the prevention of relapse in patients after complete eradication of low grade gastric lymphoma III Determine the natural history of unresected or partially resected low grade gastric lymphoma treated medically
OUTLINE This is a randomized study Patients are randomized to receive chlorambucil or placebo Patients receive omeprazole daily for 1 week Clarithromycin and tinidazole are administered twice daily for 1 week for the eradication of H pylori infection Patients are assessed every 2-3 months by endoscopy Patients may receive a maximum of 3 courses of treatment every 2-3 months Other regimens may be used if full eradication of H pylori is not achieved Patients who achieve complete response eradication of H pylori are randomized to receive oral chlorambucil or placebo daily for 14 days Treatment is repeated every 28 days for 6 courses Patients are followed every 6 months for 2 years then yearly thereafter
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
OUTLINE This is a randomized study Patients are randomized to receive chlorambucil or placebo Patients receive omeprazole daily for 1 week Clarithromycin and tinidazole are administered twice daily for 1 week for the eradication of H pylori infection Patients are assessed every 2-3 months by endoscopy Patients may receive a maximum of 3 courses of treatment every 2-3 months Other regimens may be used if full eradication of H pylori is not achieved Patients who achieve complete response eradication of H pylori are randomized to receive oral chlorambucil or placebo daily for 14 days Treatment is repeated every 28 days for 6 courses Patients are followed every 6 months for 2 years then yearly thereafter
PROJECTED ACCRUAL A total of 200 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 |
|---|---|---|---|
| EU-98040 | None | None | None |
| BNLI-LY03 | None | None | None |