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

NCT ID: NCT02520479

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2018-01-31

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.

Conditions

Treatment Refusal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

P-CHOP

Intervention Type: 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

Radiotherapy

Intervention Type: 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.

P-CHOP

Intervention Type: DRUG

Two "consolidation" cycles of P-CHOP are given after radiotherapy

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: RADIATION

P-CHOP

Two "consolidation" cycles of P-CHOP are given after radiotherapy

Intervention Type: DRUG

Other Intervention Names

CTX, VCR, ADM , DXM, Pegaspargase; radiotherapy after induction chemotherapy; CTX, VCR, ADM , DXM, Pegaspargase

Eligibility Criteria

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)

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

wanghua

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

minghuang hong, MD.

Role: STUDY_DIRECTOR

Clinical Research Center

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

NK-SYSUCC

Identifier Type: -

Identifier Source: org_study_id