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A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma


Phase 2
18 Years
75 Years
Not Enrolling
Both
Lymphoma, T-Cell

Thank you

Trial Information

A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma


Inclusion Criteria:



- Pathologically confirmed NK/T-cell lymphoma

- Localized (Ann Arbor stage I/II) disease

- At least one measurable lesion

- Age > 18

- ECOG performance status 0 - 2

- Expected life span of at least 12 weeks

- Normal marrow function (hemoglobin ≥ 9.0 g/dL; absolute neutrophil count ≥ 1,500/mm3;
platelet count ≥ 100,000/mm3)

- Normal liver function (total bilirubin < 2x upper limit of normal [ULN], transaminase
< 3x ULN)

- Normal renal function (serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 50
mL/min)

- Written informed consent

Exclusion Criteria:

- Other malignancies except for treated non-melanoma skin cancers and cervical cancer
in situ

- Serious medical illnesses (congestive heart failure, angina, respiratory failure, and
renal failure)

- Acute or active infection requiring intravenous (IV) antibiotics

- Pregnant, lactating women

- Previous history of chemotherapy or radiotherapy

- Concomitant medication that may influence the study drugs

- Allergic reaction to study drugs

- Grade 2 or greater peripheral neuropathy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Won Seog Kim, MD, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

2004-10-08

NCT ID:

NCT00418535

Start Date:

April 2006

Completion Date:

July 2009

Related Keywords:

  • Lymphoma, T-Cell
  • Lymphoma, NK/T-Cell
  • Lymphoma
  • Lymphoma, T-Cell

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