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

September 19, 2013 updated by: Lymphoma Trials Office

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lymphoma Trials Office

Investigators

  • Study Chair: Barry W. Hancock, MD, Cancer Research Centre at Weston Park Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1995

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

March 11, 2004

First Posted (Estimate)

March 12, 2004

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066695
  • BNLI-LY03
  • EU-98040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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