Combine GELOX With Concurrent Radiation Therapy for Patients With Stage IE/IIE ENKTL

NCT02080234 | Unknown Phase 2

• 1 other identifier: GELOX1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of first-line gemcitabine, oxaliplatin, and asparaginase (GELOX) with concurrent involved-field radiation therapy for patients in newly diagnosed stage IE/IIE ENKTL.

Conditions

Lymphoma, Extranodal NK-T-Cell

Keywords

Lymphoma, Extranodal NK-T-Cell; asparaginase; GELOX; concurrent chemoradiotherapy; sIL-2R

Outcome Measures

Primary Outcomes (1)

• complete remission rate

  1.The criteria for the efficacy evaluation (overall response rate and 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)

• safety

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

Other Outcomes (3)

• Epstein-Barr virus(EBV) DNA copies

  Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months)

• Plasma β2-microglobulin

  every 3 weeks,up to completion of treatment(approximately 6 months)

• serum sIL-2R level

  every 3 weeks,up to completion of treatment(approximately 6 months)

Study Arms (1)

concurrent chemoradiotherapy with GELOX

EXPERIMENTAL

GELOX: gemcitabine ：1250mg/m2 (ivdrip) on days 1, oxaliplatin :85 mg/m2 (ivdrip) on day 1, and pegaspargase : 2500 IU/m2 (intramuscular injection) on day 1.Cycle is repeated every 14 days IFRT IFRT is delivered using 6-MeV linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions. the first cycle of chemotherapy was initiated on the same day of radiotherapy.

Drug: GELOX; Radiation: IFRT

Interventions

GELOX DRUG

gemcitabine ：1250mg/m2 (ivdrip) on days 1, oxaliplatin :85 mg/m2 (ivdrip) on day 1, and pegaspargase : 2500 IU/m2 (intramuscular injection) on day 1.Cycle is repeated every 14 days

Also known as: gemcitabine, oxaliplatin, asparaginase, pegaspargase

concurrent chemoradiotherapy with GELOX

IFRT RADIATION

IFRT is delivered using 6-MeV linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions

concurrent chemoradiotherapy with GELOX

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; State Key Laboratory of Oncology in South China,

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Gelox; Gemcitabine; Oxaliplatin; Asparaginase; pegaspargase

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• ZhongJun Xia, MD/PHD

  Department of Hematological Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,

  PRINCIPAL INVESTIGATOR

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: March 2, 2014
• First Posted: March 6, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

CN (1)