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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292695
First Posted: February 16, 2006
Last Update Posted: October 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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: None (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:


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


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy.
  4. ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood.
  5. Age <70.
  6. 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):
Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT00292695     History of Changes
Other Study ID Numbers: T1405
First Submitted: February 15, 2006
First Posted: February 16, 2006
Last Update Posted: October 30, 2013
Last Verified: October 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
Ifosfamide
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors