Gastric CancerPhase 3NCT00003617
Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach
A Phase 3 study testing chlorambucil, clarithromycin and omeprazole in people with Gastric Cancer, run by Lymphoma Trials Office at 30 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- chlorambucil, clarithromycin and omeprazole
- How many people
- 200 participants
- Where
- 30 sitesin 5 countries
- Study dates
- Mar 1995to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
United Kingdom26 sites
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, HP21 8AL
Bradford Hospitals NHS Trust
Bradford, England, BD9 6RJ
Kent and Canterbury Hospital
Canterbury, England, CT2 7NR
Essex County Hospital
Colchester, England
Walsgrave Hospital
Coventry, England, CV2 2DX
Royal Free Hospital
Hampstead, London, England, NW3 2QG
Ipswich Hospital NHS Trust
Ipswich, England, IP4 5PD
Kettering General Hosptial
Kettering, Northants, NNI6 8UZ
Leeds Teaching Hospital Trust
Leeds, England, LS1 3EX
Charing Cross Hospital
London, England, W6 8RF
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
Milton Keynes General Hospital
Milton Keynes, England, MK6 5LD
James Paget Hospital
Norfolk, NR31 6LA
Mount Vernon Hospital
Northwood, England, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Peterborough Hospitals Trust
Peterborough, England, PE3 6DA
Rotherham District General Hospital-NHS Trust
Rotherham, S60 2UD
Salford Royal Hospitals NHS Trust
Salford, England, M6 8HD
Salisbury District Hospital
Salisbury, SP2 8BJ
Weston Park Hospital
Sheffield, England, S1O 2SJ
Staffordshire General Hospital
Stafford, ST16 3SA
Royal Marsden Hospital
Sutton, England, SM2 5PT
Good Hope Hospital Trust
West Midlands, England, B75 7RR
Southend NHS Trust Hospital
Westcliff-on-Sea, England
York District Hospital
York, England, Y031 8HE
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- chlorambucil, clarithromycin, omeprazole, tinidazole
- Keywords
- stage I gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorambucilDrug
clarithromycinDrug
omeprazoleDrug
tinidazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2004 (estimated)
- Study startMar 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lymphoma Trials Office
- Sponsor type
- University, hospital or other
- Investigators
- Barry W. Hancock, MD, Study chair, Cancer Research Centre at Weston Park Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003617
- Sponsor's protocol ID
- CDR0000066695
- Other IDs
- BNLI-LY03, EU-98040
- Status last verified
- Apr 2009
- First submitted
- 1 Nov 1999
- Last updated
- 20 Sep 2013
- Results posted
- No
Publications
Hancock BW, Qian W, Linch D, Delchier JC, Smith P, Jakupovic I, Burton C, Souhami R, Wotherspoon A, Copie-Bergman C, Capella C, Traulle C, Levy M, Cortelazzo S, Ferreri AJ, Ambrosetti A, Pinotti G, Martinelli G, Vitolo U, Cavalli F, Gisselbrecht C, Zucca E. Chlorambucil versus observation after anti-Helicobacter therapy in gastric MALT lymphomas: results of the international randomised LY03 trial. Br J Haematol. 2009 Feb;144(3):367-75. doi: 10.1111/j.1365-2141.2008.07486.x. Epub 2008 Nov 22.
PubMed 19036078Bertoni F, Conconi A, Capella C, Motta T, Giardini R, Ponzoni M, Pedrinis E, Novero D, Rinaldi P, Cazzaniga G, Biondi A, Wotherspoon A, Hancock BW, Smith P, Souhami R, Cotter FE, Cavalli F, Zucca E; International Extranodal Lymphoma Study Group; United Kingdom Lymphoma Group. Molecular follow-up in gastric mucosa-associated lymphoid tissue lymphomas: early analysis of the LY03 cooperative trial. Blood. 2002 Apr 1;99(7):2541-4. doi: 10.1182/blood.v99.7.2541.
PubMed 11895791Zucca E, Roggero E, Delchier J, et al.: Interim evaluation of gastric malt lymphoma response to antibiotics in the ongoing LY03 randomized cooperative trial of observation vs chlorambucil after anti-helicobacter therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A12, 2000.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Randomised Trial of Observation Versus Chlorambucil After Anti-Helicobacter Therapy in Low Grade Gastric Lymphoma
- ClinicalTrials.gov ID
- NCT00003617
- Acronym / sponsor ID
- CDR0000066695
- Conditions
- Gastric Cancer
- Keywords
- stage I gastric cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lymphoma Trials OfficeUniversity, hospital or other
- Study start
- Mar 1995
- First posted
- 12 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chlorambucil | Drug | – |
| clarithromycin | Drug | – |
| omeprazole | Drug | – |
| tinidazole | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Results publication: PubMed 19036078Hancock BW, Qian W, Linch D, Delchier JC, Smith P, Jakupovic I, Burton C, Souhami R, Wotherspoon A, Copie-Bergman C, Capella C, Traulle C, Levy M, Cortelazzo S, Ferreri AJ, Ambrosetti A, Pinotti G, Martinelli G, Vitolo U, Cavalli F, Gisselbrecht C, Zucca E. Chlorambucil versus observation after anti-Helicobacter therapy in gastric MALT lymphomas: results of the international randomised LY03 trial. Br J Haematol. 2009 Feb;144(3):367-75. doi: 10.1111/j.1365-2141.2008.07486.x. Epub 2008 Nov 22.
- Results publication: PubMed 11895791Bertoni F, Conconi A, Capella C, Motta T, Giardini R, Ponzoni M, Pedrinis E, Novero D, Rinaldi P, Cazzaniga G, Biondi A, Wotherspoon A, Hancock BW, Smith P, Souhami R, Cotter FE, Cavalli F, Zucca E; International Extranodal Lymphoma Study Group; United Kingdom Lymphoma Group. Molecular follow-up in gastric mucosa-associated lymphoid tissue lymphomas: early analysis of the LY03 cooperative trial. Blood. 2002 Apr 1;99(7):2541-4. doi: 10.1182/blood.v99.7.2541.
- Results publicationZucca E, Roggero E, Delchier J, et al.: Interim evaluation of gastric malt lymphoma response to antibiotics in the ongoing LY03 randomized cooperative trial of observation vs chlorambucil after anti-helicobacter therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A12, 2000.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry W. Hancock, MD study chair
Cancer Research Centre at Weston Park Hospital
30 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chlorambucil, clarithromycin and omeprazole in people with Gastric Cancer, run by Lymphoma Trials Office at 30 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United Kingdom, Hong Kong, Poland, South Africa, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003617, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.