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A phase I/II study of intra-maxillary arterial infusion chemotherapy with concomitant radiotherapy for localized nasal NK/T-cell lymphoma

A phase I/II study of intra-maxillary arterial infusion chemotherapy with concomitant radiotherapy for localized nasal NK/T-cell lymphoma - A phase I/II study of arterial infusion concurrent chemoradiotherapy for localized nasal NK/T-cell lymphoma (MPVIC-P/RT)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016795
Enrollment
6
Registered
2015-04-01
Start date
2015-04-01
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

localized nasal NK/T-cell lymphoma

Interventions

Concurrent intra-arterial MPVIC-P chemotherapy and radiotherapy with 54Gy

Sponsors

Department of Otolaryngology-Head and Neck Surgery, Asahikawa Medical university
Lead Sponsor

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 involvemen 4) Aged 20 to 75 years old 5) Performance status (PS) of 0-1 on ECOG (Eastern Cooperative Oncology Group) scale 6) No prior chemotherapy or radiotherapy 7) Patients not requiring systemic corticosteroid therapy after registration 8) Adequate organ function 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Clinical symptoms of Central nervous system involvement 2)Uncontrollable diabetes mellitus and/or hypertension 3) Uncontrollable myocardial infarction, angina, and/or cardiomyopathy 4) Positive test for HIV antibody 5) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema 6) Severe infection 7) Liver cirrhosis 8) Other active malignancies 9) Pregnant, possible pregnant, or breastfeeding woman 10) Use of major tranquilizer, antidepressant, or antimanic 11) Severe psychosis

Design outcomes

Primary

MeasureTime frame
Toxicity, 2-year overall survival rate

Secondary

MeasureTime frame
Complete response rate, 2-year progression-free survival rate, pattern of failure, adverse events

Countries

Japan

Contacts

Public ContactToshihiro Nagato

Asahikawa Medical university Department of Otolaryngology-Head and Neck Surgery

rijun@asahikawa-med.ac.jp0166-68-2554

Outcome results

None listed

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