A phase I/II study of concurrent chemoradiotherapy (RT-DeVIC) for newly-diagnosed, localized nasal NK/T-cell lymphoma (JCOG0211-DI)

A phase I/II study of concurrent chemoradiotherapy (RT-DeVIC) for newly-diagnosed, localized nasal NK/T-cell lymphoma (JCOG0211-DI) - A phase I/II study of concurrent chemoradiotherapy (RT-DeVIC) for newly-diagnosed, localized nasal NK/T-cell lymphoma (JCOG0211-DI)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007842

Enrollment

Registered

2012-04-27

Start date

2003-09-01

Completion date

Unknown

Last updated

2026-06-29

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

Interventions

Concurrent chemoradiotherapy comprising radiotherapy of 50 - 50.4 Gy and 3 cycles of DeVIC chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed extranodal NK/T-cell lymphoma, nasal type 2) Lymphomatous involvement in nasal cavity and/or its adjacent site(s) 3) Stage IE or contiguous stage IIE with cervical lymph node involvement 4) Aged 20 to 69 years old 5) Performance status (PS) of 0-2 on ECOG (Eastern Cooperative Oncology Group) scale 6) Measureable lesion present 7) No prior chemotherapy or radiotherapy 8) Patients not requiring systemic corticosteroid therapy after registration 9) Adequate organ function 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Clinical symptoms of Central nervous system involvement 2) Uncontrollable diabetes mellitus 3) Uncontrollable hypertension 4) History of myocardial infarction or angina, and/or cardiomyopathy, and/or arrhythmia treated with antiarrhythmic 5) Positive test for HBs antigen 6) Positive test for HIV antibody 7) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema 8) Severe infection 9) Liver cirrhosis 10) Other active malignancies 11) Pregnant, possible pregnant, or breastfeeding woman 12) Use of major tranquilizer, antidepressant, or antimanic 13) Severe psychosis 14) Patients or their families, and/or attending physicians hoping hematopoietic stem cell transplantation after obtained responses by RT-DeVIC

Design outcomes

Primary

Measure	Time frame
Phase I portion: toxicity Phase II portion: 2-year overall survival rate	—

Secondary

Measure	Time frame
Phase II portion: Complete response rate, 2-year progression-free survival rate, 2-year planning target volume control, pattern of failure, adverse events, late adverse reactions due to radiation Long-term follow-up: 5-year overall survival rate, 5-year progression-free survival rate, 5-year planning target volume control, pattern of failure, adverse events, late adverse reactions due to radiation	—

Measure

Time frame

Phase II portion: Complete response rate, 2-year progression-free survival rate, 2-year planning target volume control, pattern of failure, adverse events, late adverse reactions due to radiation Long-term follow-up: 5-year overall survival rate, 5-year progression-free survival rate, 5-year planning target volume control, pattern of failure, adverse events, late adverse reactions due to radiation

—

Countries

Japan

Contacts

Public ContactMotoko Yamaguchi, M.D., Ph.D.

JCOG0211-DI Coordinating Office Department of Hematology and Oncology, Mie University Graduate School of Medicine

waniwani@clin.medic.mie-u.ac.jp059-231-5418

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026