A Phase II Study of Nasal NK/T-Cell Lymphoma

This study is currently recruiting participants.

Verified by National Health Research Institutes, Taiwan, February 2006

First Received: February 15, 2006 No Changes Posted

Sponsored by:	National Health Research Institutes, Taiwan
Information provided by:	National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:	NCT00292695

Purpose

To determine whether adding combinational chemotherapy concurrently to conventional radiation will improve the response rate, event-free survival, and overall survival. To test the dose intensity and toxicity of chemotherapy in concurrence with radiation.

To detect the blood EBV DNA level in Chinese Nasal NK/T-cell lymphoma patients and correlate to the treatment response and prognosis.

Condition	Intervention	Phase
Lymphoma	Drug: Dexamethosone, VP-16, Cisplatin, Ifosfamide, Mesna, IF-RT	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Cisplatin Mesna Ifosfamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Concurrent Chemoradiation for The Localized Nasal NK/T-Cell Lymphoma

Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:

CR rate

Secondary Outcome Measures:

2-year overall survival and 5-year overall survival , event-free survival, toxicity.

Estimated Enrollment:	30
Study Start Date:	February 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, while CD56+ is not an essential diagnostic criteria. ). Newly diagnosed patients.
Any of lymphomatous involvement exist in nasal cavity and/or paranasal sinuses, orbit, Waldeyer’s ring, and oral cavity performance status with ECOG scale 0-2.
Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy.
ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood.
Age <70.
Total bilirubin ＜ 2.5 mg/dl, Serum creatinine ≦1.5 mg/dl, Blood urea nitrogen (BUN) ≦ 25 mg/dl

Exclusion Criteria:

1.Pregnancy or lactation period 2.Severe intercurrent illness, eg. Infection, heart failure 3.Myocardial infarction within recent 12 months 4.Known hypersensitivity to any component drug of the treatment regimen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292695

Contacts

Contact: Yung-Hsin Chin, RN

886-2-87923311 ext 17643

yhchin@nhri.org.tw

Locations

Taiwan
National Health Research Institutes, Lymphoma Disease Committee	Recruiting
Taipei, Taiwan
Contact: Hui-Ju Ch'ang, co-PI, M.D. 886-2-23562959 ext 7678 hjmc@nhri.org.tw
Principal Investigator: Tsu-Yi Chao, M.D. PHD
Principal Investigator: Li-Tzong Chen, M.D.PHD
Principal Investigator: Ann-Lii Cheng, M.D. PHD

Sponsors and Collaborators

National Health Research Institutes, Taiwan

Investigators

Principal Investigator:

Ming-Chih Chang, M.D.

Lymphoma Disease Committee of Taiwan Cooperative Oncology Group

More Information

No publications provided

Study ID Numbers:	T1405
Study First Received:	February 15, 2006
Last Updated:	February 15, 2006
ClinicalTrials.gov Identifier:	NCT00292695 History of Changes
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Lymphatic Diseases
Ifosfamide
Immunoproliferative Disorders
Cisplatin
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders
Mesna
Etoposide phosphate
Etoposide
Lymphoma
Isophosphamide mustard

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases

Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009