NCT01238159

Brief Summary

The purpose of this study is to evaluate the efficacy of concomitant chemoradiation followed by MIDLE chemotherapy for stage I/II extranodal NK/T cell lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2010

Typical duration for phase_2

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

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 10, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

4.3 years

First QC Date

September 8, 2010

Last Update Submit

March 1, 2015

Conditions

Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type

Keywords

Natural killer cellT cellLymphomaRadiationChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Complete response

    The response criteria was based on the International Working Group Report (1999).

    Within 4 weeks after the completion of planned treatment

Secondary Outcomes (3)

  • Overall response rate

    Up to 2 years

  • overall survival

    up to 2 years

  • Progression-free survival

    up to 2 years

Study Arms (1)

CCRT+MIDLE

EXPERIMENTAL

Patients who are planned to be treated with CCRT plus MIDLE chemotherapy. CCRT means concurrent chemoradiation, and MIDLE represent systemic chemotherapy.

Radiation: CCRT+MIDLE chemotherapy

Interventions

CCRT+MIDLE chemotherapyRADIATION

Patients are planned to be treated with CCRT plus MIDLE chemotherapy

Also known as: Chemoradiotherapy
CCRT+MIDLE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients were required to have a biopsy-proven diagnosis of nasal ENKTL
  • at least 18 years old
  • Ann Arbor stage IE or IIE
  • measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 life expectancy greater than 12 weeks
  • adequate hematologic (hemoglobin \> 9.0 g/dL, absolute neutrophil count \> 1,500/uL and platelets \> 100,000/uL)
  • renal (serum creatinine \< 1.5 mg/dL, creatinine clearance \> 50 mL/min)
  • hepatic (total bilirubin \< 2 times of upper limit of normal and aspartate transferase \< 3 times of upper limit of normal) function
  • Diagnosis of ENKTL is based on the presence of histological features and immunophenotypes compatible with ENKTL (e.g., cytoplasmic CD3+, CD20-, CD56+,
  • positive for cytotoxic molecules
  • positive for EBV by in situ hybridization).
  • Informed consent

You may not qualify if:

  • prior or concomitant malignant tumors
  • any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
  • ENKTL with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.
  • Other subtypes of non-Hodgkin lymphoma (NHL), including myeloid/NK cell precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified, were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135710, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-CellLymphoma

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Won Seog Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 8, 2010

First Posted

November 10, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations

KR(1)