Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach
- Conditions
- Gastric Cancer
- Registration Number
- NCT00003617
- Lead Sponsor
- Lymphoma Trials Office
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
Leeds Teaching Hospital Trust
🇬🇧Leeds, England, United Kingdom
Essex County Hospital
🇬🇧Colchester, England, United Kingdom
Ipswich Hospital NHS Trust
🇬🇧Ipswich, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Peterborough Hospitals Trust
🇬🇧Peterborough, England, United Kingdom
Good Hope Hospital Trust
🇬🇧West Midlands, England, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Southend NHS Trust Hospital
🇬🇧Westcliff-On-Sea, England, United Kingdom
James Paget Hospital
🇬🇧Norfolk, United Kingdom
Rotherham District General Hospital-NHS Trust
🇬🇧Rotherham, United Kingdom
Frere Hospital
🇿🇦Central Region, South Africa
Oncology Centre Institute
🇵🇱Warsaw, Poland
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, United Kingdom
Stoke Mandeville Hospital
🇬🇧Aylesbury-Buckinghamshire, England, United Kingdom
Royal Free Hospital
🇬🇧Hampstead, London, England, United Kingdom
Kettering General Hosptial
🇬🇧Kettering, Northants, United Kingdom
Staffordshire General Hospital
🇬🇧Stafford, United Kingdom
Bradford Hospitals NHS Trust
🇬🇧Bradford, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Ospedale San Giovanni
🇨🇭Bellinzona, Switzerland
Milton Keynes General Hospital
🇬🇧Milton Keynes, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
🇬🇧London, England, United Kingdom
Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Salford Royal Hospitals NHS Trust
🇬🇧Salford, England, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, England, United Kingdom
York District Hospital
🇬🇧York, England, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong