Multicenter Cross Sectional Study of Primary Intestine Lymphoma

Samsung Medical Center

Status: Completed

Conditions: Non-Hodgkin Lymphoma of Intestine

Study type: Observational

Funder types: Other

Identifiers

NCT01043302

2008-09-060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 545 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

545 participants in 2 patient groups

Surgery+chemotherapy

Description:

Primary mass was resected and systemic chemotherapy was performed as an adjuvant treatment

Chemotherapy

Description:

Only treated with chemotherapy