|
Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach Clinical research trials and Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach. Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach clinical trial. Participants frequently get the best healthcare available for their Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach
Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach
For Condition: stage 1 gastric cancer
Status: No longer recruiting
Sponsor(s): British National Lymphoma Investigation ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 16 and over - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
B.W.Hancock, Study Chair, British National Lymphoma Investigation
Charing Cross Hospital
London, England, W6 8RF
United Kingdom
James Paget Hospital
Norfolk, , NR31 6LA
United Kingdom
Peterborough Hospitals Trust
Peterborough, England, PE3 6DA
United Kingdom
Ospedale San Giovanni
Bellinzona, , CH-6500
Switzerland
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, HP21 8AL
United Kingdom
Frere Hospital
Central Region, ,
South Africa
Ipswich Hospital NHS Trust
Ipswich, England, IP4 5PD
United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
United Kingdom
Milton Keynes General Hospital
Milton Keynes, England, MK6 5LD
United Kingdom
Bradford Hospitals NHS Trust
Bradford, England, BD9 6RJ
United Kingdom
Queen Mary Hospital
Hong Kong, ,
Hong Kong
Good Hope Hospital Trust
West Midlands, England, B75 7RR
United Kingdom
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
United Kingdom
Royal Free Hospital
Hampstead, London, England, NW3 2QG
United Kingdom
Mount Vernon Hospital
Northwood, England, HA6 2RN
United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
United Kingdom
Salford Royal Hospitals NHS Trust
Salford, England, M6 8HD
United Kingdom
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Salisbury District Hospital
Salisbury, , SP2 8BJ
United Kingdom
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Leeds Teaching Hospital Trust
Leeds, England, LS1 3EX
United Kingdom
Walsgrave Hospital
Coventry, England, CV2 2DX
United Kingdom
Oncology Centre Institute
Warsaw, , 02 781
Poland
Kettering General Hosptial
Kettering, Northants, , NNI6 8UZ
United Kingdom
Rotherham District General Hospital-NHS Trust
Rotherham, , S60 2UD
United Kingdom
Essex County Hospital
Colchester, England,
United Kingdom
Staffordshire General Hospital
Stafford, , ST16 3SA
United Kingdom
Kent and Canterbury Hospital
Canterbury, England, CT2 7NR
United Kingdom
York District Hospital
York, England, Y031 8HE
United Kingdom
Southend NHS Trust Hospital
Westcliff-On-Sea, England,
United Kingdom
Additional Information:
Study ID Numbers: CDR0000066695; BNLI-LY03,EU-98040
Study Start Date: March 1995
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003617
Other Stage 1 Gastric Cancer Studies:
1. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
2. Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
3. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
4. Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
5. Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach
Related Studies:
Other stage 1 gastric cancer Clinical Trials
Other England Clinical Trials
Other Milton Keynes Clinical Trials
Chlorambucil Compared With No Further Therapy Following Anti- Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach
|
|
|
|
|
|
|
|