"Sandwich" Chemotherapy With Radiotherapy in Newly Diagnosed, Stage IE to IIE, ENKTL

Sun Yat-sen University

Status and phase: Terminated; Phase 2

Conditions: Treatment Refusal

Treatments: Drug: P-CHOP; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02520479

NK-SYSUCC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

sandwich protocols

Experimental group

Description:

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.

Treatment:

Radiation: Radiotherapy

Drug: P-CHOP

Drug: P-CHOP