Multicenter Cross Sectional Study of Primary Intestine Lymphoma

Non-Hodgkin Lymphoma of Intestine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043302
• Other study ID #: 2008-09-060
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: July 27, 2010
• Start date: September 2008
• Est. completion date: March 2010

Study information

• Verified date: July 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 85 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma of Intestine

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Study entry	No
Secondary	Quality of life		Study entry	No