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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01667302

Enrollment

Registered

2012-08-17

Start date

2012-06-30

Completion date

2016-12-31

Last updated

2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Keywords

NK/T-cell lymphoma, Radiotherapy, Adjuvant chemotherapy

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.

Detailed description

For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.

Interventions

DRUGRadiotherapy followed by chemotherapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
3-year Progression-free survival	3 years

Secondary

Measure	Time frame
Overall response rate	3 years
3-year overall survival	3 years
Safety	3 years

Countries

China

Contacts

Primary ContactYe Guo, MD

pattrick_guo@msn.com862164175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026