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

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Lymphoma, T-Cell

Treatments: Drug: Concurrent Radiotherapy (RT)/cisplatin, VIPD

Study type: Interventional

Funder types: Other

Identifiers

NCT00418535

2004-10-08

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)