NCT01667289

Brief Summary

The purpose of this study is to prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk NK/T-cell lymphoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

3 years

First QC Date

August 13, 2012

Last Update Submit

March 2, 2013

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Keywords

NK/T-cell lymphomaMethotrexateRadiotherapyConcurrent chemoradiation

Outcome Measures

Primary Outcomes (1)

  • 3-year Progression-free survival

    3 years

Secondary Outcomes (2)

  • Overall response rate

    3 years

  • 3-year overall survival

    3 years

Study Arms (2)

Radiotherapy alone

ACTIVE COMPARATOR

Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy

Radiation: Radiotherapy alone

Concurrent chemoradiation

EXPERIMENTAL

Concurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy

Radiation: Radiotherapy aloneDrug: Concurrent chemoradiation

Interventions

Radiotherapy aloneRADIATION

Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy

Concurrent chemoradiationRadiotherapy alone
Concurrent chemoradiationDRUG

Concurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy

Also known as: MTX
Concurrent chemoradiation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range 18-75 years old
  • Histological confirmed, previously untreated stage IE nasal NK/T cell lymphoma without following risk factors including local invasion, B symptoms and high LDH level
  • ECOG performance status 0-1
  • Life expectancy of more than 3 months
  • Adequate bone marrow and organ functions

You may not qualify if:

  • non-nasal NK/T-cell lymphoma
  • Prior exposure of methotrexate
  • With third space effusion
  • Pregnant or lactating women
  • Serious uncontrolled diseases and intercurrent infection
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ye Guo, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assocaite Director of Medical Oncology Department

Study Record Dates

First Submitted

August 13, 2012

First Posted

August 17, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2017

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

CN(1)