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Completed

NCT Number: NCT01264822

Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori

To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori

Completed

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Key information

Conditions

Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • gastric low-grade mucosa-associated lymphoid tissue (MALT) lymphoma with Helicobacter pylori positive
  • The stages of MALT lymphoma are Lugano International Conference classification Stage I or II 1 and Wotherspoon grade 4 or 5

Exclusion criteria

  • With diffuse large B-cell lymphoma
  • Have been treated to gastric mucosa-associated lymphoid tissue (MALT) lymphoma
  • Corresponding to contraindication of each drug

Treatment and study plan

RABEPRAZOLE SODIUM

Drug

The following 3 drugs are taken orally at the same time twice daily for 7 days: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and clarithromycin 200 mg.

The dose of clarithromycin may be properly increased as needed, although the upper limit is 400 mg twice daily.

If Helicobacter pylori eradication with proton pump inhibitor, amoxicillin, and clarithromycin fails, the following 3 drugs will be taken at the same time twice daily for 7 days as an alternative treatment for adults: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and metronidazole 250 mg.

Primary outcomes

  1. Response rate of gastric low-grade MALT lymphoma by eradication of Helicobacter pylori

    Time frame: Every 3 months within the 1st year and every 6 months

  2. Transition rate to secondary therapy for eradication of Helicobacter pylori

    Time frame: Every 6 months within the 1st year and every 12 months as needed

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2010
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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