Spots Global Cancer Trial Database for Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach
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Trial Identification
Brief Title: Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach
Official Title: Protocol for a Randomised Trial of Observation Versus Chlorambucil After Anti-Helicobacter Therapy in Low Grade Gastric Lymphoma
Study ID: NCT00003617
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Queen Mary Hospital, Hong Kong, , Hong Kong
Oncology Centre Institute, Warsaw, , Poland
Frere Hospital, Central Region, , South Africa
Ospedale San Giovanni, Bellinzona, , Switzerland
Stoke Mandeville Hospital, Aylesbury-Buckinghamshire, England, United Kingdom
Bradford Hospitals NHS Trust, Bradford, England, United Kingdom
Kent and Canterbury Hospital, Canterbury, England, United Kingdom
Essex County Hospital, Colchester, England, United Kingdom
Walsgrave Hospital, Coventry, England, United Kingdom
Royal Free Hospital, Hampstead, London, England, United Kingdom
Ipswich Hospital NHS Trust, Ipswich, England, United Kingdom
Leeds Teaching Hospital Trust, Leeds, England, United Kingdom
Charing Cross Hospital, London, England, United Kingdom
Middlesex Hospital- Meyerstein Institute, London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England, United Kingdom
Milton Keynes General Hospital, Milton Keynes, England, United Kingdom
Mount Vernon Hospital, Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
Peterborough Hospitals Trust, Peterborough, England, United Kingdom
Salford Royal Hospitals NHS Trust, Salford, England, United Kingdom
Weston Park Hospital, Sheffield, England, United Kingdom
Royal Marsden Hospital, Sutton, England, United Kingdom
Good Hope Hospital Trust, West Midlands, England, United Kingdom
Southend NHS Trust Hospital, Westcliff-On-Sea, England, United Kingdom
York District Hospital, York, England, United Kingdom
Kettering General Hosptial, Kettering, Northants, , United Kingdom
James Paget Hospital, Norfolk, , United Kingdom
Rotherham District General Hospital-NHS Trust, Rotherham, , United Kingdom
Salisbury District Hospital, Salisbury, , United Kingdom
Staffordshire General Hospital, Stafford, , United Kingdom
Contact Details
Name: Barry W. Hancock, MD
Affiliation: Cancer Research Centre at Weston Park Hospital
Role: STUDY_CHAIR
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