Multicenter Cross Sectional Study of Primary Intestine Lymphoma

NCT ID: NCT01043302

Last Updated: 2010-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

545 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Non-Hodgkin Lymphoma of Intestine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Surgery+chemotherapy

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

No interventions assigned to this group

Chemotherapy

Only treated with chemotherapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Principal Investigators

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Seok Jin Kim, MD.,PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim SJ, Kang HJ, Kim JS, Oh SY, Choi CW, Lee SI, Won JH, Kim MK, Kwon JH, Mun YC, Kwak JY, Kwon JM, Hwang IG, Kim HJ, Park J, Oh S, Huh J, Ko YH, Suh C, Kim WS. Comparison of treatment strategies for patients with intestinal diffuse large B-cell lymphoma: surgical resection followed by chemotherapy versus chemotherapy alone. Blood. 2011 Feb 10;117(6):1958-65. doi: 10.1182/blood-2010-06-288480. Epub 2010 Dec 9.

Reference Type DERIVED
PMID: 21148334 (View on PubMed)

Other Identifiers

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2008-09-060

Identifier Type: -

Identifier Source: org_study_id

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