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
  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: Endpoint Classification: Safety/Efficacy Study
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:


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 ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
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

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  Contacts and Locations
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

No publications provided

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
Health Authority: Taiwan: Department of Health

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014