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

NCT00292695 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2013-10-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Kaohsiung Medical University

    collaborator OTHER

  • Changhua Christian Hospital

    collaborator OTHER

  • Buddhist Tzu Chi General Hospital

    collaborator OTHER

  • Mackay Memorial Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Taichung Veterans General Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Kaohsiung Veterans General Hospital.

    collaborator OTHER

  • National Taiwan University Hospital

    collaborator OTHER

  • Tri-Service General Hospital

    collaborator OTHER

  • Chi Mei Medical Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Ming-Chih Chang, M.D. · Lymphoma Disease Committee of Taiwan Cooperative Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00292695 on ClinicalTrials.gov