Safety & Efficacy of Peg-ASP-based CCRT in Early Stage ENKTL

NCT ID: NCT06406556

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2026-03-01

Brief Summary

The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of concurrent chemoradiotherapy by using single-drug pegaspargase for patients with ENKTL in stage IE to IIE.

Detailed Description

The treatment regimen included CCRT ( involved field radiotherapy 50GY, concurrent 2 cycles of pegaspargase treatment ) followed by 4 cycles of pegaspargase. Chemotherapy and RT were performed simultaneously within one week after enrollment. The administration regimen was as follows : day1, deep intramuscular injection of 2500 unit/m2 pegaspargase at three different sites, and repeated once every 3 weeks. 3D conformal radiotherapy was performed using 4 or 6 MV photons generated by a linear accelerator. The radiation dose was 50 Gy, 2.0 Gy / time, 1 time / d, for 5 weeks. The clinical target volume ( CTV ) of limited stage IE patients was defined as bilateral nasal cavity, bilateral ethmoid sinus and ipsilateral maxillary sinus. The CTV of extensive stage IE patients was extended to the affected tissues. The CTV of stage IIE lesions also included the involved cervical lymph node area.

Conditions

Extranodal NK/T-cell Lymphoma

Study Design

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

Study Groups

Patients diagnosed with early ENKTL.

Patients received 4 cycles of pegaspargase including CCRT ( involved field radiotherapy 50GY, concurrent 2 cycles of pegaspargase treatment ).

Group Type: EXPERIMENTAL

Pegaspargase combined with concurrent radiotherapy.

Intervention Type: COMBINATION_PRODUCT

Patients receive CCRT (radiation 50 Gy and two cycles of pegaspargase 2500 unit/m2 every 3 weeks). 4 courses of pegaspargase were performed after CCRT.

Interventions

Pegaspargase combined with concurrent radiotherapy.

Patients receive CCRT (radiation 50 Gy and two cycles of pegaspargase 2500 unit/m2 every 3 weeks). 4 courses of pegaspargase were performed after CCRT.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1.The patient was pathologically diagnosed as ENKTL and had not received any previous treatment for ENKTL;2.The estimated survival time ≥ 3 months. 3.18-75 years old ; 4. Ann-Arbor stage was IE-IIE ; 5. ECOG performance status 0-2 ; 6.Clinicians judged that patients were suitable for concurrent chemoradiotherapy ; 7.No radiotherapy or hormone drugs were received within 4 weeks before treatment;8.After the patients were enrolled in the trial, they could not accept other drugs that may have therapeutic effects on ENKTL ; 9.WBC≥ 3 × 109 / L, NE ≥ 1.5 × 109 / L, PLT ≥ 100 × 109 / L ; 10.Serum creatinine ≤ 1.5mg / dL, creatinine clearance rate ≥ 50mL / min ; 11.ALT, AST ≤ 3 × ULN ( normal upper limit ) ; total bilirubin ≤ 2 × ULN ; 12.Serum fibrinogen level ≥ 1.0g / L ; 13.Signed informed consent form.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Hua Wang

Associate senior doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hua Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-senU

Locations

HuaWang

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hua Wang, MD

Role: CONTACT

wanghua@sysucc.org.cn

15920352412

Facility Contacts

Hua Wang, MD

Role: primary

wagnhua@sysucc.org.cn

15920352412

Other Identifiers

B2018-053

Identifier Type: -

Identifier Source: org_study_id