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

NCT ID: NCT00418535

Last Updated: 2009-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-07-31

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.

Conditions

Lymphoma, T-Cell

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Concurrent Radiotherapy (RT)/cisplatin, VIPD

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: collaborator

Gyeongsang National University Hospital

OTHER

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

CISL (Consortium to Improve Lymphoma Survival)

Principal Investigators

Won Seog Kim, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2004-10-08

Identifier Type: -

Identifier Source: org_study_id