GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma

Not Applicable

Completed

• Conditions: Extranodal NK-T-Cell Lymphoma, Nasal Type
• Interventions: Drug: GELAD; Radiation: Radiotherapy

• Registration Number: NCT02733458
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide, pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.

Detailed Description

Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with additional two cycles GELAD chemotherapy. The efficacy and safety of this sandwiched chemoradiotherapy in the treatment of stage IE/IIE ENKTCL will be measured.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-11
• Primary Completion: 2021-04
• Study Completion: 2021-04
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type, previously untreated
• Eastern Cooperative Oncology Group (ECOG ) performance status 0~3
• Stage IE to IIE disease with at least one measurable lesion in the nasal cavity, paranasal sinuses, orbit, pharynx, Waldeyer's ring, or oral cavity.
• Preserved organ functions for: absolute neutrophil counter (ANC)>1.0×109/L, Platelet>50×109/L, hemoglobin>80g/L, total bilirubin (TBIL)<2×ULN, alanine transaminase (ALT)<2×ULN, serum creatinine<1.5×ULN，fibrinogen≥1.0g/L, LVEF≥50%
• No history of chemotherapy or radiotherapy.
• Signed Informed consented

Exclusion Criteria

• Concurrent cancers need surgery or chemotherapy within 6 months.
• Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis.
• Mental disorders.
• Pregnant or lactation
• HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml.
• History of pancreatitis
• Known history for grade 3/4 allergy to the drugs in chemotherapy regimen.
• Enrolled in other trial treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GELAD/Radiation	Radiotherapy	Patients will be initially treated with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with another two cycles GELAD chemotherapy. GELAD chemotherapy will be repeated every 21 days. Radiotherapy will be delivered in 25-32 fractions.
GELAD/Radiation	GELAD	Patients will be initially treated with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with another two cycles GELAD chemotherapy. GELAD chemotherapy will be repeated every 21 days. Radiotherapy will be delivered in 25-32 fractions.

Primary Outcome Measures

Name	Time	Method
Complete response rate	28 days after 4 cycles of chemotherapy	The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.

Secondary Outcome Measures

Name	Time	Method
Overall Response rate	28 days after 4 cycles of chemotherapy	The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Progression free survival	2-year	Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Day 1 of each course and then every 3 months for 2 years	Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Overall survival	2-year	Overall survival is defiend as the time from entry onto the treatment until death of any reason

Trial Locations

Locations (7)

Shanghai Ninth Peoples' Hospital; 🇨🇳 Shanghai, China

Shanghai Eye and ENT Hospital of Fudan University; 🇨🇳 Shanghai, China

Shanghai Dong Fang hospital; 🇨🇳 Shanghai, Shanghai, China

Department of Hematology, Renji Hospital; 🇨🇳 Shanghai, Shanghai, China

Xin Jiang People's Hospital; 🇨🇳 Urumqi, Xinjiang, China

South Renji hospital; 🇨🇳 Shanghai, Shanghai, China

Xinhua Hospital; 🇨🇳 Shanghai, China