Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date October 2016
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The extranodal natural killer/T-cell lymphoma (ENKTL) shows high local or systemic failure rates when radiotherapy (RT) is taken as the primary treatment, suggesting a role for chemotherapy (CT) added to RT for this disease. However, the appropriate mode of combined modality therapy (CMT) has not been fully defined.We conducted a prospective phase II study of "Sandwich" Pegaspargase, cyclophosphamide,vincristine, doxorubicin and dexamethasone (P-CHOP) regimen in combination with radiotherapy.The "sandwich" protocols, refer to earlier RT after an initial 2 cycles of P-CHOP followed by further two "consolidation" cycles.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
P-CHOP
Two cycles of P-CHOP:cyclophosphamide, 750 mg/m2 day 1; vincristine,(maximal dose 2 mg),adriamycin , 50 mg/m2 day 1; dexamethasone,10mg days 1-8; Pegaspargase, 2500IU/m2 day 1 are given before radiotherapy
Radiation:
Radiotherapy
Radiotherapy was scheduled after 2 cycles of P-CHOPregimen. Involved field radiotherapy(IFRT) is delivered using 6-Million electron Volts linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions.
Drug:
P-CHOP
Two "consolidation" cycles of P-CHOP are given after radiotherapy

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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)
See also
  Status Clinical Trial Phase
Recruiting NCT03893136 - The Registry Study of Takayasu Arteritis in East China
Completed NCT00433134 - Survey of Adherence to Immunosuppression and Other Medications in Kidney Transplant Patients N/A
Recruiting NCT05465408 - Culturally Aware AET Non-Initiation Intervention N/A
Recruiting NCT05722197 - Assessment of Emotion Regulation Strategies Used When Suicidal N/A
Recruiting NCT02705508 - PEG-ASP, Etoposide and Gemcitabine for Natural Killer/T Lymphoma Phase 2
Enrolling by invitation NCT04098588 - Behavioral Economics Intervention to Increase Treatment Seeking in the National Guard N/A
Completed NCT01829789 - Individual vs. Group Community Reinforcement Training to Help Parents of Substance-using Treatment-refusing Youth N/A