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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sandwich protocols | Experimental | sandwich protocols: Patients with newly diagnosed ENKTL is given 2 cycles of P-CHOP[cyclophosphamide(CTX), 750 mg/m2 day 1; vincristine(VCR), 1.4 mg/m2 day 1 (maximal dose 2 mg),adriamycin(ADM) 50 mg/m2 day 1; dexamethasone(DXM) 10 mg days 1-8; Pegaspargase 2500 international unit day 1] before radiotherapy(RT) and then two "consolidation" cycles after RT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P-CHOP | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| minghuang hong, MD. | Clinical Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D016312 | Treatment Refusal |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C042705 | pegaspargase |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Radiotherapy | Radiation | 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. |
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| P-CHOP | Drug | Two "consolidation" cycles of P-CHOP are given after radiotherapy |
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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) |
| 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) |