A Phase II Study of Nasal NK/T-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00292695|
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : October 30, 2013
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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. ]
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
|National Health Research Institutes, Lymphoma Disease Committee|
|Principal Investigator:||Ming-Chih Chang, M.D.||Lymphoma Disease Committee of Taiwan Cooperative Oncology Group|