A Phase II Study of Nasal NK/T-cell Lymphoma
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| ClinicalTrials.gov Identifier: NCT00292695 |
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Recruitment Status :
Completed
First Posted : February 16, 2006
Last Update Posted : October 30, 2013
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Other: VP-16, Cisplatin, Ifosfamide, Dexamethosone, Mesna, IF-RT | Phase 2 |
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| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 33 participants |
| 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 |
| Study Start Date : | May 2006 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | December 2010 |
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
- tumor response by CT scan or MRI [ Time Frame: the first course of DVIP, one month after the last course of DVIP ]
- EBV DNA level, AEs, Withdrawal from the study treatment [ Time Frame: 2-year overall survival and 5-year overall survival , event-free survival, toxicity. ]
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| Ages Eligible for Study: | up to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
- Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy.
- ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood.
- Age <70.
- 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
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
| Taiwan | |
| National Health Research Institutes, Lymphoma Disease Committee | |
| Taipei, Taiwan | |
| Principal Investigator: | Ming-Chih Chang, M.D. | Lymphoma Disease Committee of Taiwan Cooperative Oncology Group |
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 Posted: | February 16, 2006 Key Record Dates |
| Last Update Posted: | October 30, 2013 |
| Last Verified: | October 2013 |
Additional relevant MeSH terms:
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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 |