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

Condition(s) targeted: Gastric Cancer

Intervention: chlorambucil (Drug); clarithromycin (Drug); omeprazole (Drug); tinidazole (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Lymphoma Trials Office

Official(s) and/or principal investigator(s):
Barry W. Hancock, MD, Study Chair, Affiliation: Cancer Research Centre at Weston Park Hospital

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.

Official title: Protocol for a Randomised Trial of Observation Versus Chlorambucil After Anti-Helicobacter Therapy in Low Grade Gastric Lymphoma

Study design: Treatment, Randomized

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.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Queen Mary Hospital, Hong Kong, Hong Kong

Oncology Centre Institute, Warsaw 02 781, Poland

Frere Hospital, Central Region, South Africa

Ospedale San Giovanni, Bellinzona CH-6500, Switzerland

James Paget Hospital, Norfolk NR31 6LA, United Kingdom

Kettering General Hosptial, Kettering, Northants NNI6 8UZ, United Kingdom

Rotherham District General Hospital-NHS Trust, Rotherham S60 2UD, United Kingdom

Salisbury District Hospital, Salisbury SP2 8BJ, United Kingdom

Staffordshire General Hospital, Stafford ST16 3SA, United Kingdom

Bradford Hospitals NHS Trust, Bradford, England BD9 6RJ, United Kingdom

Charing Cross Hospital, London, England W6 8RF, United Kingdom

Clatterbridge Centre for Oncology NHS Trust, Merseyside, England L63 4JY, United Kingdom

Essex County Hospital, Colchester, England, United Kingdom

Good Hope Hospital Trust, West Midlands, England B75 7RR, United Kingdom

Ipswich Hospital NHS Trust, Ipswich, England IP4 5PD, United Kingdom

Kent and Canterbury Hospital, Canterbury, England CT2 7NR, United Kingdom

Leeds Teaching Hospital Trust, Leeds, England LS1 3EX, United Kingdom

Middlesex Hospital- Meyerstein Institute, London, England WIT 3AA, United Kingdom

Milton Keynes General Hospital, Milton Keynes, England MK6 5LD, United Kingdom

Mount Vernon Hospital, Northwood, England HA6 2RN, United Kingdom

Nottingham City Hospital NHS Trust, Nottingham, England NG5 1PB, United Kingdom

Peterborough Hospitals Trust, Peterborough, England PE3 6DA, United Kingdom

Royal Free Hospital, Hampstead, London, England NW3 2QG, United Kingdom

Royal Marsden Hospital, Sutton, England SM2 5PT, United Kingdom

Salford Royal Hospitals NHS Trust, Salford, England M6 8HD, United Kingdom

Southend NHS Trust Hospital, Westcliff-On-Sea, England, United Kingdom

Stoke Mandeville Hospital, Aylesbury-Buckinghamshire, England HP21 8AL, United Kingdom

Walsgrave Hospital, Coventry, England CV2 2DX, United Kingdom

Weston Park Hospital, Sheffield, England S1O 2SJ, United Kingdom

York District Hospital, York, England Y031 8HE, United Kingdom

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 1995
Last updated: May 23, 2008