Clinical trial NCT02733458: GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extranodal NK-T-Cell Lymphoma, Nasal Type
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete response rate
timeFrame: 28 days after 4 cycles of chemotherapy
Secondary outcomes:
measure: Progression free survival
timeFrame: 2-year
measure: Overall Response rate
timeFrame: 28 days after 4 cycles of chemotherapy
measure: Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Day 1 of each course and then every 3 months for 2 years
measure: Overall survival
timeFrame: 2-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Dong Fang hospital
state: Shanghai
city: Shanghai
country: China
facility: Department of Hematology, Renji Hospital
state: Shanghai
city: Shanghai
country: China
facility: South Renji hospital
state: Shanghai
city: Urumqi
country: China
facility: Xin Jiang People's Hospital
state: Xinjiang
city: Shanghai
country: China
facility: Shanghai Ninth Peoples' Hospital
city: Shanghai
country: China
facility: Shanghai Eye and ENT Hospital of Fudan University
city: Shanghai
country: China
facility: Xinhua Hospital
Study officials:
affiliation: Xinhua hospital, Shanghai Jiao Tong University of Medicine
name: Rong Tao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu Y, Tian S, Xu L, Ma Y, Zhang W, Wang L, Jin L, Liu C, Zhu C, Li Z, Hao S, Zhong H, Ding H, Tao R. GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T-cell lymphoma: a prospective multicentre study. Br J Haematol. 2022 Feb;196(4):939-946. doi: 10.1111/bjh.17960. Epub 2021 Nov 21.