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Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003617
Recruitment Status : Unknown
Verified April 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : March 12, 2004
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: chlorambucil Drug: clarithromycin Drug: omeprazole Drug: tinidazole Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Protocol for a Randomised Trial of Observation Versus Chlorambucil After Anti-Helicobacter Therapy in Low Grade Gastric Lymphoma
Study Start Date : March 1995

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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Endoscopically diagnosed, unresected, partially resected, or completely resected low grade (stage I) gastric lymphoma Prior diagnosis of H. pylori infection No nodal metastases Microbiological evidence of current H. pylori infection required No pathological evidence of enlarged abdominal lymph nodes by CT scan Gastroscopic ultrasound evidence of enlarged nodes allowed, if CT scan normal

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003617

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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Oncology Centre Institute
Warsaw, Poland, 02 781
South Africa
Frere Hospital
Central Region, South Africa
Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
United Kingdom
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom, HP21 8AL
Bradford Hospitals NHS Trust
Bradford, England, United Kingdom, BD9 6RJ
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT2 7NR
Essex County Hospital
Colchester, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom, CV2 2DX
Royal Free Hospital
Hampstead, London, England, United Kingdom, NW3 2QG
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom, IP4 5PD
Leeds Teaching Hospital Trust
Leeds, England, United Kingdom, LS1 3EX
Charing Cross Hospital
London, England, United Kingdom, W6 8RF
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, WIT 3AA
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom, L63 4JY
Milton Keynes General Hospital
Milton Keynes, England, United Kingdom, MK6 5LD
Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Peterborough Hospitals Trust
Peterborough, England, United Kingdom, PE3 6DA
Salford Royal Hospitals NHS Trust
Salford, England, United Kingdom, M6 8HD
Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Good Hope Hospital Trust
West Midlands, England, United Kingdom, B75 7RR
Southend NHS Trust Hospital
Westcliff-On-Sea, England, United Kingdom
York District Hospital
York, England, United Kingdom, Y031 8HE
Kettering General Hosptial
Kettering, Northants, United Kingdom, NNI6 8UZ
James Paget Hospital
Norfolk, United Kingdom, NR31 6LA
Rotherham District General Hospital-NHS Trust
Rotherham, United Kingdom, S60 2UD
Salisbury District Hospital
Salisbury, United Kingdom, SP2 8BJ
Staffordshire General Hospital
Stafford, United Kingdom, ST16 3SA
Sponsors and Collaborators
Lymphoma Trials Office
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Study Chair: Barry W. Hancock, MD Cancer Research Centre at Weston Park Hospital

Publications of Results:
Layout table for additonal information Identifier: NCT00003617     History of Changes
Other Study ID Numbers: CDR0000066695
First Posted: March 12, 2004    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: April 2009

Keywords provided by National Cancer Institute (NCI):
stage I gastric cancer

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents