Multicenter Cross Sectional Study of Primary Intestine Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01043302
First received: January 4, 2010
Last updated: July 27, 2010
Last verified: July 2010
  Purpose

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.


Condition
Non-Hodgkin Lymphoma of Intestine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Multicenter Cross Sectional Study of Primary Intestine Lymphoma: Treatment Outcome and Quality of Life

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Study entry ] [ Designated as safety issue: No ]

Enrollment: 545
Study Start Date: September 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgery+chemotherapy
Primary mass was resected and systemic chemotherapy was performed as an adjuvant treatment
Chemotherapy
Only treated with chemotherapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

University hosptial, general hospital, Cancer institute

Criteria

Inclusion Criteria:

  • Primary intestine lymphoma.

Definition of primary intestine lymphoma:

  1. Dominant site should be small and large intestine with or without regional lymph node involvement
  2. Distant lymph node involvement can be allowed if the intestine lesion is the presenting site
  3. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043302

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Seok Jin Kim, MD.,PhD Samsung Medical Center
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim, Seok Jin, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01043302     History of Changes
Other Study ID Numbers: 2008-09-060
Study First Received: January 4, 2010
Last Updated: July 27, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
lymphoma, intestine, outcome, quality of life

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 22, 2014