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

-

  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

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 July 28, 2014