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Completed

NCT Number: NCT01043302

Multicenter Cross Sectional Study of Primary Intestine Lymphoma

The purpose of this study is to determine whether whether surgical resection followed by chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and quality of life (QOL) in patients with primary intestinal lymphoma.

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Key information

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

Intestine is the one of commonly involved extranodal sites of non-Hodgkin's lymphoma (NHL). Thus, small and large Intestine account for approximately 30-40% of primary gastrointestinal tract lymphoma. More than 70% of intestinal lymphoma presents as localized disease, and surgery such as bowel resection is performed in many patients with intestinal lymphoma for diagnosis and treatment. However, it is still unclear whether surgical resection followed by chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and quality of life (QOL). Thus, we analyze the clinical features and treatment outcome of patients with NHL of intestine, and at the same time perform a multicenter cross-sectional study about the QOL in survivors of intestine NHL. We evaluates the treatment outcomes of patients with intestine NHL from hospitals affiliated with the Consortium for Improving Survival of Lymphoma (CISL) in Korea. We assess the QOL of survivors who completed their treatment using the EORTC QLQ-C30 questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary intestine lymphoma.

Definition of primary intestine lymphoma:

  • Dominant site should be small and large intestine with or without regional lymph node involvement
  • Distant lymph node involvement can be allowed if the intestine lesion is the presenting site
  • Contiguous involvement of other organs such as liver, spleen can be allowed

Exclusion criteria

  • Intestine involvement as a dissemination process in stage IV nodal lymphoma

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: Study entry

Secondary outcomes

  1. Quality of life

    Time frame: Study entry

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Multicenter Cross Sectional Study of Primary Intestine Lymphoma: Treatment Outcome and Quality of Life

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 6, 2010
Registry last updated
Jul 28, 2010

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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