NCT01043302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
545

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 28, 2010

Status Verified

July 1, 2010

Enrollment Period

1.5 years

First QC Date

January 4, 2010

Last Update Submit

July 27, 2010

Conditions

Non-Hodgkin Lymphoma of Intestine

Keywords

lymphoma, intestine, outcome, quality of life

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Study entry

Secondary Outcomes (1)

  • Quality of life

    Study entry

Study Arms (2)

Surgery+chemotherapy

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

Chemotherapy

Only treated with chemotherapy

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

University hosptial, general hospital, Cancer institute

You may qualify if:

  • Primary intestine lymphoma.
  • Definition of primary intestine lymphoma:
  • Dominant site should be small and large intestine with or without regional lymph node involvement
  • Distant lymph node involvement can be allowed if the intestine lesion is the presenting site
  • Contiguous involvement of other organs such as liver, spleen can be allowed

You may not qualify if:

  • Intestine involvement as a dissemination process in stage IV nodal lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 21148334DERIVED

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Seok Jin Kim, MD.,PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 6, 2010

Study Start

September 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 28, 2010

Record last verified: 2010-07

Locations

KR(1)