Clinical trial NCT02386813: International Extranodal NK/T-cell Lymphoma Project
Official title: International Extranodal NK/T-cell Lymphoma Project: Prognostic Factors in the Era of Nonanthracycline-based Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Seok Jin Kim
name: Consortium for Improving Survival of Lymphoma
name: Asia Lymphoma Study Group
name: Lymphoma Study Association
name: Dok Hyun Yoon
name: Arnaud Jaccard
name: Wee Joo Chng
name: Soon Thye Lim
name: Huangming Hong
name: Yong Park
name: Kian Meng Chang
name: Yoshinobu Maeda
name: Fumihiro Ishida
name: Dong-Yeop Shin
name: Jin Seok Kim
name: Seong Hyun Jeong
name: Deok-Hwan Yang
name: Jae-Cheol Jo
name: Gyeong-Won Lee
name: Chul Won Choi
name: Won-Sik Lee
name: Tsai-Yun Chen
name: Kiyeun Kim
name: Sin-Ho Jung
name: Tohru Murayama
name: Yasuhiro Oki
name: Ranjana Advani
name: Francesco d'Amore
name: Norbert Schmitz
name: Cheolwon Suh
name: Ritsuro Suzuki
name: Yok Lam Kwong
name: Tong-Yu Lin
First posted: 2015-03-12
Enrollment: 770
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Overall survival
timeFrame: 5 year
Secondary outcomes:
measure: Progression-free survival
timeFrame: 5 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Seog Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: