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

September 13, 2021 updated by: Rong Tao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Xinhua Hospital
      • Shanghai, China, 200011
        • Shanghai Ninth Peoples' Hospital
      • Shanghai, China, 200031
        • Shanghai Eye and ENT Hospital of Fudan University
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Shanghai Dong Fang Hospital
      • Shanghai, Shanghai, China, 201100
        • Department of Hematology, Renji Hospital
      • Shanghai, Shanghai, China, 201100
        • South Renji hospital
    • Xinjiang
      • Urumqi, Xinjiang, China, 830001
        • Xin Jiang People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GELAD/Radiation
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.
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
Other Names:
  • Gemcitabine, Etoposide, Dexamethasone, Pegaspargase
Radiation: Radiotherapy
Radiotherapy: 50-56Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: 28 days after 4 cycles of chemotherapy
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
28 days after 4 cycles of chemotherapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Rong Tao, MD, Xinhua hospital, Shanghai Jiao Tong University of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

April 1, 2021

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHLSG-NK-1601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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