International Extranodal NK/T-cell Lymphoma Project

Completed

• Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type

• Registration Number: NCT02386813
• Lead Sponsor: Samsung Medical Center

Brief Summary

This study is to explore risk factors for poor progression-free survival (PFS) and overall survival (OS) in ENKTL, and establish a prognostic model for ENKTL patients treated with non-anthracycline based treatment.

Detailed Description

This is a retrospective cohort study using anonymized information from patients with ENKTL. The following criteria are required: (1) Patients diagnosed with ENKTL, nasal type between January 1, 1995 and December 31, 2014; (2) Patients treated with non-anthracycline based therapy as an initial treatment. The pathology of initial diagnosis was reviewed by designated pathologists.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-08
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 770

Inclusion Criteria

• Patients diagnosed with ENKTL, nasal type
• Patients diagnosed between January 1, 1995 and December 31, 2014
• Patients treated with nonanthracycline-based therapy as the initial treatment after diagnosis
• Nonanthracycline-based therapy includes the following treatments:
• Radiotherapy including concurrent chemoradiation
• Chemotherapy not including anthracycline such as doxorubicin (e.g. SMILE, VIPD) The type of salvage treatment will not be a criterion for exclusion. Thus, patients who had received various kinds of salvage treatment including anthracycline-containing regimens can be included. Patients who had undergone autologous or allogeneic stem cell transplantation can also be included in the analysis if they satisfy the above-mentioned inclusion criteria.

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Exclusion Criteria

• Patients who had received anthracycline-based therapy, such as CHOP or CHOP-like regimens, as the initial treatment.
• Patients who do not have pathology slides available for central review.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	5 year	Time between the date of diagnosis and any kinds of death

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	5 year	Time between the date of diagnosis and any kinds of death or relapse/progression

Trial Locations

Locations (1)

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