Treatment Refusal Clinical Trial
Official title:
Phase 2 Trial of "Sandwich" Pegaspargase-CHOP Chemotherapy With Radiotherapy in Newly Diagnosed, Stage IE to IIE, Nasal Type, Extranodal Natural Killer/T-cell Lymphoma
NCT number | NCT02520479 |
Other study ID # | NK-SYSUCC |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2013 |
Est. completion date | January 2018 |
Verified date | October 2016 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A phase 2 study was conducted of "sandwich" protocols, with earlier RT after an initial 2 of P-CHOP (Pegaspargase, cyclophosphamide,vincristine, doxorubicin and dexamethasone ), followed by further two "consolidation" cycles,to explore the appropriate mode of combined modality therapy (CMT) in early stage ENKTL.
Status | Terminated |
Enrollment | 12 |
Est. completion date | January 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 69 Years |
Eligibility |
Inclusion Criteria: - newly diagnosed ENKTL - age:18-69years - Ann Arbor stage IE,or stage IIE with cervical lymph node involvement - at lease one measurable lesion - receive no chemotherapy or radiotherapy before - Eastern CooperativeOncology Group performance status of 0 to 2. - Adequate hematologic function (eg, white blood cell = 3×10e9/l,neutrophils count =1.5×10e9/L, and platelet count= 100×10e9/L),renal function (eg, serum creatinine=1.5 mg/dL and creatinine clearance =50 mL minute), and hepatic function (e.g, total bilirubin= 2 times the upper limit of normal and aspartate and alanine transaminase levels = 3 times the upper limit of normal) Exclusion Criteria: - mismatch the inclusion criteria - systematic central nervous system involvement - previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol. - primary lesion not from the upper respiratory |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | complete remission rate | The criteria for the efficacy evaluation (complete remission) of the regimen is according to the following article. Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999;17:1244 |
every 4 weeks,up to completion of treatment(approximately 6 months) | |
Secondary | progression free survival | time from the date of enrollment to date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first | up to end of follow-up-phase (approximately 3 years) | |
Secondary | overall survival | time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first. | up to end of follow-up-phase (approximately 3 years) | |
Secondary | Hematological and non-hematological safety as a measure of adverse events according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | including hematological safety and non-hematological safety. All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | up to end of follow-up-phase (approximately 3 years) |
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