Multicenter Cross Sectional Study of Primary Intestine Lymphoma

Completed

• Conditions: Non-Hodgkin Lymphoma of Intestine

• Registration Number: NCT01043302
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-27
• Last Update Posted: 2010-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 545

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	Study entry

Secondary Outcome Measures

Name	Time	Method
Quality of life	Study entry

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of