GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma
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
1 other identifier
interventional
52
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 5, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedSeptember 14, 2021
September 1, 2021
5.1 years
April 5, 2016
September 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Progression free survival
2-year
Overall Response rate
28 days after 4 cycles of chemotherapy
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Day 1 of each course and then every 3 months for 2 years
Overall survival
2-year
Study Arms (1)
GELAD/Radiation
EXPERIMENTALPatients 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Shanghai Dong Fang hospital
Shanghai, Shanghai Municipality, 200120, China
Department of Hematology, Renji Hospital
Shanghai, Shanghai Municipality, 201100, China
South Renji hospital
Shanghai, Shanghai Municipality, 201100, China
Xin Jiang People's Hospital
Ürümqi, Xinjiang, 830001, China
Shanghai Ninth Peoples' Hospital
Shanghai, 200011, China
Shanghai Eye and ENT Hospital of Fudan University
Shanghai, 200031, China
Xinhua Hospital
Shanghai, China
Related Publications (1)
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.
PMID: 34806163DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rong Tao, MD
Xinhua hospital, Shanghai Jiao Tong University of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
April 5, 2016
First Posted
April 11, 2016
Study Start
March 1, 2016
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
September 14, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share