Treatment Refusal
Conditions
Keywords
extranodal natural killer/T-cell lymphoma, nasal type, radiotherapy, chemotherapy
Brief 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.
Detailed 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.
Interventions
DRUGP-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
RADIATIONRadiotherapy
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission rate | every 4 weeks,up to completion of treatment(approximately 6 months) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | up to end of follow-up-phase (approximately 3 years) | 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 |
| overall survival | up to end of follow-up-phase (approximately 3 years) | time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first. |
| Hematological and non-hematological safety as a measure of adverse events according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | up to end of follow-up-phase (approximately 3 years) | 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) |
Countries
China
Outcome results
None listed