CCRT-VIDL
Open-labeled, Multicenter Phase II Study of Concomitant Chemo-radiotherapy Followed by VIDL Chemotherapy With Risk-based Application of Autologous Stem Cell Transplantation in Stage I/II Extranodal NK/T-cell Lymphoma
Sponsor study identifier
interventional
31
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)This study is to evaluate the efficacy of risk-adapted treatment strategy for stage I/II extranodal NK/T cell lymphoma. The risk stratification is based on the Korean NK prognostic index. Thus, the group I/II will receive concomitant chemoradiation followed by VIDL chemotherapy. The group III/IV will receive high dose-chemotherapy followed by autologous stem cell transplantation after the completion of VIDL chemotherapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
November 2, 2009
Actual (reported)November 4, 2009
Actual (reported)December 2012
Actual (reported)December 2012
Actual (reported)February 7, 2019
Actual (reported)Compete Response Rate
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
Within 3 weeks after the completion fo treatment
Overall Response Rate, Survival, Toxicity
Up to 5 years after the completion of treatment
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
CCRT followed by VIDL chemotherapy concomitant chemo-radiotherapy followed by VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) chemotherapy with risk-based application of autologous stem cell transplantation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Samsung Medical Center
Seoul, 135-710, South Korea
Won Seog Kim, MD, PhD
Samsung Medical Center
31 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2009
First Posted
November 4, 2009
Study Start
April 2008
Contact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
February 7, 2019
Results First Posted
February 7, 2019
Record last verified: 2018-09
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Source: ClinicalTrials.gov.
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