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

NCT02520479 | Terminated Phase 2 DMC

• 1 other identifier: NK-SYSUCC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Refusal

Keywords

extranodal natural killer/T-cell lymphoma; nasal type; radiotherapy; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• progression free survival

  up to end of follow-up-phase (approximately 3 years)

• overall 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)

Study Arms (1)

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.

Drug: P-CHOP; Radiation: Radiotherapy

Interventions

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

Also known as: CTX, VCR, ADM , DXM, Pegaspargase

sandwich protocols

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.

Also known as: radiotherapy after induction chemotherapy

sandwich protocols

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Treatment Refusal

Interventions

pegaspargase; Radiotherapy

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• minghuang hong, MD.

  Clinical Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 11, 2015
• Study Start: June 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: May 9, 2018

Record last verified: 2016-10

Locations

CN (1)