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

This study has been completed.

Sponsor:

Collaborators:

Mackay Memorial Hospital

National Cheng-Kung University Hospital

Taichung Veterans General Hospital

Taipei Veterans General Hospital, Taiwan

Kaohsiung Veterans General Hospital.

National Taiwan University Hospital

Tri-Service General Hospital

Chi Mei Medical Hospital

Kaohsiung Medical University

Changhua Christian Hospital

Buddhist Tzu Chi General Hospital

Information provided by (Responsible Party):

National Health Research Institutes, Taiwan

ClinicalTrials.gov Identifier:

NCT00292695

First received: February 15, 2006

Last updated: October 28, 2013

Last verified: October 2013

History of Changes

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	Other: VP-16, Cisplatin, Ifosfamide, Dexamethosone, Mesna, IF-RT	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Concurrent Chemoradiation for The Localized Nasal NK/T-cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Ifosfamide Cisplatin Mesna Etoposide Etoposide phosphate

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Extranodal Nasal NK/T Cell Lymphoma

U.S. FDA Resources

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

Primary Outcome Measures:

tumor response by CT scan or MRI [ Time Frame: the first course of DVIP, one month after the last course of DVIP ]

Secondary Outcome Measures:

EBV DNA level, AEs, Withdrawal from the study treatment [ Time Frame: 2-year overall survival and 5-year overall survival , event-free survival, toxicity. ]


Enrollment:	33
Study Start Date:	May 2006
Study Completion Date:	December 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: chemoradiation Chemoradiation: IF-RT 50.4 Gy/28 Fractions, DEP: (Q4W, CCRT) X 2 Dexamethosone 20 mg/m2/d iv D1-3 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-3 Cisplatin 75 mg/m2 ivd 4 hr D1	Other: VP-16, Cisplatin, Ifosfamide, Dexamethosone, Mesna, IF-RT IF-RT 50.4 Gy/28 Fractions, DEP: (Q4W, CCRT) X 2 Dexamethosone 20 mg/m2/d iv D1-3 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-3 Cisplatin 75 mg/m2 ivd 4 hr D1 DVIP: (Q4W, POST-RT) X 2 Dexamethosone 20 mg/m2/d iv D1-4 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-4 Ifosfamide 1.2 gm/m2/d ivd 2 hr D1-4 Mesna 240 mg/m2/d iv at 0, 4, 8 hr D1-4 Cisplatin 20 mg/m2 ivd 1 hr D1-4 G-CSF 250ug subcut D 9-12

Arms

Assigned Interventions

Experimental: chemoradiation

Chemoradiation: IF-RT 50.4 Gy/28 Fractions, DEP: (Q4W, CCRT) X 2 Dexamethosone 20 mg/m2/d iv D1-3 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-3 Cisplatin 75 mg/m2 ivd 4 hr D1

Other: VP-16, Cisplatin, Ifosfamide, Dexamethosone, Mesna, IF-RT

IF-RT 50.4 Gy/28 Fractions, DEP: (Q4W, CCRT) X 2 Dexamethosone 20 mg/m2/d iv D1-3 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-3 Cisplatin 75 mg/m2 ivd 4 hr D1

DVIP: (Q4W, POST-RT) X 2 Dexamethosone 20 mg/m2/d iv D1-4 VP-16 (etoposide) 75 mg/m2 iv 1 hr D1-4 Ifosfamide 1.2 gm/m2/d ivd 2 hr D1-4 Mesna 240 mg/m2/d iv at 0, 4, 8 hr D1-4 Cisplatin 20 mg/m2 ivd 1 hr D1-4 G-CSF 250ug subcut D 9-12

Show Detailed Description

Eligibility


Ages Eligible for Study:	up to 70 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Taiwan
National Health Research Institutes, Lymphoma Disease Committee
Taipei, Taiwan

Sponsors and Collaborators

National Health Research Institutes, Taiwan

Mackay Memorial Hospital

National Cheng-Kung University Hospital

Taichung Veterans General Hospital

Taipei Veterans General Hospital, Taiwan

Kaohsiung Veterans General Hospital.

National Taiwan University Hospital

Tri-Service General Hospital

Chi Mei Medical Hospital

Kaohsiung Medical University

Changhua Christian Hospital

Buddhist Tzu Chi General Hospital

Investigators


Principal Investigator:	Ming-Chih Chang, M.D.	Lymphoma Disease Committee of Taiwan Cooperative Oncology Group

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tsai HJ, Lin SF, Chen CC, Chen TY, Su WC, Hwang WL, Lin JC, Chiou TJ, Kao WY, Chiu CF, Chang YF, Chang JS, Chang MC, Su IJ. Long-term results of a phase II trial with frontline concurrent chemoradiotherapy followed by consolidation chemotherapy for localized nasal natural killer/T-cell lymphoma. Eur J Haematol. 2015 Feb;94(2):130-7. doi: 10.1111/ejh.12405. Epub 2014 Oct 10.


Responsible Party:	National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:	NCT00292695 History of Changes
Other Study ID Numbers:	T1405
Study First Received:	February 15, 2006
Last Updated:	October 28, 2013

Additional relevant MeSH terms:


Lymphoma Lymphoma, T-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Isophosphamide mustard Cisplatin	Etoposide Ifosfamide Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents

ClinicalTrials.gov processed this record on June 23, 2017

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