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

Extranodal NK-T-Cell Lymphoma, Nasal Type Clinical Trial

Official title:

The Efficacy and Safety of Gemcitabine, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (GELAD) With Sandwiched Radiotherapy in the Treatment of Stage IE/II Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733458
• Other study ID #: XHLSG-NK-1601
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: April 2021

Study information

• Verified date: September 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Extranodal NK-T-Cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• GELAD
Gemcitabine, 1.0g/m2/d IV, day 1 Etoposide, 60mg/m2 IV, day 1 to day 3 Dexamethasone, 40mg/d IV, day 1 to day 4 Pegaspargase, 2000IU/m2/d IM, day 4

Radiation:
• Radiotherapy
Radiotherapy: 50-56Gy

Locations

Country	Name	City	State
China	Department of Hematology, Renji Hospital	Shanghai	Shanghai
China	Shanghai Dong Fang hospital	Shanghai	Shanghai
China	Shanghai Eye and ENT Hospital of Fudan University	Shanghai
China	Shanghai Ninth Peoples' Hospital	Shanghai
China	South Renji hospital	Shanghai	Shanghai
China	Xinhua Hospital	Shanghai
China	Xin Jiang People's Hospital	Urumqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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