Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma

A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00418535

Enrollment

Unknown

Registered

2007-01-05

Start date

2006-04-30

Completion date

2009-07-31

Last updated

2009-10-21

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

Conditions

Lymphoma, T-Cell

Keywords

Lymphoma, NK/T-Cell

Brief summary

Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. The efficacy of the conventional anthracycline-based chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone \[CHOPP\]) has been unsatisfactory. The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal dose, sequence, and multi-modality treatment with involved field radiotherapy still need to be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized NK/T-cell lymphoma patients.

Interventions

DRUGConcurrent Radiotherapy (RT)/cisplatin, VIPD

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Pathologically confirmed NK/T-cell lymphoma * Localized (Ann Arbor stage I/II) disease * At least one measurable lesion * Age \> 18 * ECOG performance status 0 - 2 * Expected life span of at least 12 weeks * Normal marrow function (hemoglobin ≥ 9.0 g/dL; absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3) * Normal liver function (total bilirubin \< 2x upper limit of normal \[ULN\], transaminase \< 3x ULN) * Normal renal function (serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 50 mL/min) * Written informed consent

Exclusion criteria

* Other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ * Serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure) * Acute or active infection requiring intravenous (IV) antibiotics * Pregnant, lactating women * Previous history of chemotherapy or radiotherapy * Concomitant medication that may influence the study drugs * Allergic reaction to study drugs * Grade 2 or greater peripheral neuropathy

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026