Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma
A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 13, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 5, 2013
March 1, 2013
1.5 years
August 13, 2012
March 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year Progression-free survival
3 years
Secondary Outcomes (3)
Overall response rate
3 years
3-year overall survival
3 years
Safety
3 years
Study Arms (1)
Radiotherapy followed by chemotherapy
EXPERIMENTALRadiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1
Interventions
Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1
Eligibility Criteria
You may qualify if:
- Age range 14-70 years old
- Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
- ECOG performance status 0-1
- Life expectancy of more than 3 months
- Without prior history of pancreatitis
- Adequate bone marrow and organ functions
You may not qualify if:
- Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level)
- Pregnant or lactating women
- With contraindication of steroid including uncontrolled diabetes
- 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
- Fudan Universitylead
Study Sites (1)
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
Liu Y, Xue K, Xia Z, Jin J, Wang J, Sun H, Lv F, Liu X, Cao J, Hong X, Guo Y, Ma X, Zhang Q. Radiotherapy followed by DICEP regimen in treatment of newly diagnosed, stage IE/IIE, extranodal NK/T-cell lymphoma patients. Cancer Med. 2020 Aug;9(15):5400-5405. doi: 10.1002/cam4.3207. Epub 2020 Jun 9.
PMID: 32519518DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ye Guo, MD
Fudan University
Central Study Contacts
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
- 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
December 1, 2013
Study Completion
December 1, 2016
Last Updated
March 5, 2013
Record last verified: 2013-03