Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma (CCRT-VIDL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01007526
Recruitment Status : Completed
First Posted : November 4, 2009
Results First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
Asan Medical Center
National Cancer Center, Korea
Severance Hospital
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition NK/T-cell Lymphoma of Nasal Cavity
Intervention Other: CCRT followed by VIDL chemotherapy
Enrollment 31
Recruitment Details Recruitment between August 2008 and October 2010 Location: University hospital or Institutes
Pre-assignment Details  
Arm/Group Title CCRT Plus VIDL
Hide Arm/Group Description CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
Period Title: Overall Study
Started 31
Completed 31
Not Completed 0
Arm/Group Title CCRT Plus VIDL
Hide Arm/Group Description CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  87.1%
>=65 years
4
  12.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
47.1  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
11
  35.5%
Male
20
  64.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 31 participants
31
1.Primary Outcome
Title Compete Response Rate
Hide Description Response was determined by the revised response criteria for malignant lymphoma (Cheson BD et al. J Clin Oncol. 2007 Feb 10;25(5):579-86.): 1) Complete response 2) Partial response 3) Stable disease 4) Progressive disease
Time Frame Within 3 weeks after the completion fo treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CCRT Plus VIDL
Hide Arm/Group Description:
CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
31
2.Secondary Outcome
Title Overall Response Rate, Survival, Toxicity
Hide Description [Not Specified]
Time Frame Up to 5 years after the completion of treatment
Outcome Measure Data Not Reported
Time Frame 6 months after registration
Adverse Event Reporting Description We applied the same definition as the clinicaltrials.gov.
 
Arm/Group Title CCRT Plus VIDL
Hide Arm/Group Description CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
All-Cause Mortality
CCRT Plus VIDL
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CCRT Plus VIDL
Affected / at Risk (%) # Events
Total   0/31 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CCRT Plus VIDL
Affected / at Risk (%) # Events
Total   30/30 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia   30/30 (100.00%)  30
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Won Seog Kim
Organization: Samsung Medical Center
Phone: 82234106548
Responsible Party: Won Seog Kim, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01007526     History of Changes
Other Study ID Numbers: 2008-04-033
First Submitted: November 2, 2009
First Posted: November 4, 2009
Results First Submitted: December 30, 2012
Results First Posted: February 7, 2019
Last Update Posted: February 7, 2019