Back to resultsGELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma
Primary Purpose
Extranodal NK-T-Cell Lymphoma, Nasal Type
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GELAD
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Extranodal NK-T-Cell Lymphoma, Nasal Type
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
Sites / Locations
- Shanghai Dong Fang hospital
- Department of Hematology, Renji Hospital
- South Renji hospital
- Xin Jiang People's Hospital
- Shanghai Ninth Peoples' Hospital
- Shanghai Eye and ENT Hospital of Fudan University
- Xinhua Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GELAD/Radiation
Arm Description
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.
Outcomes
Primary Outcome Measures
Complete response rate
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Secondary Outcome Measures
Progression free survival
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Overall Response rate
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Overall survival
Overall survival is defiend as the time from entry onto the treatment until death of any reason
Full Information
NCT ID
NCT02733458
First Posted
April 5, 2016
Last Updated
September 13, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02733458
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
April 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK-T-Cell Lymphoma, Nasal Type
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GELAD/Radiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GELAD
Other Intervention Name(s)
Gemcitabine, Etoposide, Dexamethasone, Pegaspargase
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy: 50-56Gy
Primary Outcome Measure Information:
Title
Complete response rate
Description
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Time Frame
28 days after 4 cycles of chemotherapy
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Time Frame
2-year
Title
Overall Response rate
Description
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Time Frame
28 days after 4 cycles of chemotherapy
Title
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Description
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Time Frame
Day 1 of each course and then every 3 months for 2 years
Title
Overall survival
Description
Overall survival is defiend as the time from entry onto the treatment until death of any reason
Time Frame
2-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Tao, MD
Organizational Affiliation
Xinhua hospital, Shanghai Jiao Tong University of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Dong Fang hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Department of Hematology, Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201100
Country
China
Facility Name
South Renji hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201100
Country
China
Facility Name
Xin Jiang People's Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Facility Name
Shanghai Ninth Peoples' Hospital
City
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Shanghai Eye and ENT Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
Xinhua Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34806163
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.
Results Reference
derived
Learn more about this trial
GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma
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