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
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- complete remission rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Arms & Interventions
sandwich protocols
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.
Intervention: Radiotherapy (Radiation)
sandwich protocols
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.
Intervention: P-CHOP (Drug)
Outcomes
Primary Outcomes
complete remission rate
Time Frame: 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 Outcomes
- progression free survival(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)(up to end of follow-up-phase (approximately 3 years))
- overall survival(up to end of follow-up-phase (approximately 3 years))
Investigators
wanghua
professor
Sun Yat-sen University