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

Lymphoma, Extranodal NK-T-Cell Clinical Trial

Official title:

Combination of Gemcitabine, Oxaliplatin, and Asparaginase (GELOX) With Concurrent Involved-Field Radiation Therapy for Patients With Stage IE/IIE Extranodal Natural Killer/T-Cell Lymphoma:a Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02080234
• Other study ID #: GELOX1
• Status: Recruiting
• Phase: Phase 2
• First received: March 2, 2014
• Last updated: April 18, 2016
• Start date: March 2014
• Est. completion date: March 2017

Study information

• Verified date: April 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

1. Patients

• All patients should sign a written informed consent form before enrollment, and the study should be approved by the Sun Yat-sen University Cancer Center Ethics Board.

• Baseline of patients: Computed tomography (CT) scans of the chest, abdomen, and pelvis, magnetic resonance imaging studies of the head and neck, and bilateral bone marrow aspiration or biopsy. Positron emission tomography-CT scans (optional). Epstein-Barr virus (E B V) DNA blood levels, titer of EBV antibody (EA-IgA, VCA-IgA), β2-micro globulin (β2-MG) and soluble CD 25 (sCD 25) in the serum.

• Recheck before and after every course: Epstein-Barr virus (EBV) DNA blood levels, titer of EBV antibody (EA-IgA, VCA-IgA), β2-micro globulin (β2-MG) and soluble CD 25 (sCD25) in the serum.

• Recheck every two course: Computed tomography (CT) scans of the chest, abdomen, and pelvis, magnetic resonance imaging studies of the head and neck, and bilateral bone marrow aspiration or biopsy. Positron emission tomography-CT scans (optional)

2. Treatment Protocol - The GELOX regimen consist of the following drugs: gemcitabine ：1250 mg/ m2 on days 1,ivdrip oxaliplatin ：85 mg/m2 on day 1, ivdrip pegaspargase : 2500 IU/m 2 daily on day 1,intramuscular The treatment cycle was repeated every 14 days.

• IFRT was delivered using 6-MeV linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions, we define the clinical target volume of limited stage IE disease as the bilateral nasal cavity, bilateral ethmoid sinuses, and ipsilateral maxillary sinus; and the clinical target volume would extend to involved tissues for patients who had extensive stage IE disease. For patients who had stage IIE disease, the clinical target volume also, included the bilateral cervical lymph node area.

• Disease Progression during the treatment should be treated with second-line therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, Extranodal NK-T-Cell

Intervention

Drug:
• 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

Radiation:
• 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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Epstein-Barr virus(EBV) DNA copies		Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months)	No
Other	Plasma ß2-microglobulin		every 3 weeks,up to completion of treatment(approximately 6 months)	No
Other	serum sIL-2R level		every 3 weeks,up to completion of treatment(approximately 6 months)	No
Primary	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)	No
Secondary	progression free survival	progression free survival(PFS): time from the date of enrollment to date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first	up to end of follow-up-phase (approximately 3 years)	No
Secondary	overall survival	overall survival (OS): time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first.	up to end of follow-up-phase (approximately 3 years)	No
Secondary	safety	including hematological safety and non-hematological safety.All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)	up to end of follow-up-phase (approximately 3 years)	Yes