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NCT02733458 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
NA
Status at capture
COMPLETED
Registry last update
2021-09-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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
healthy Volunteers
false
maximum Age
75 Years
minimum Age
15 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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 Names
    1. Drug: GELAD
    2. Radiation: Radiotherapy
    label
    GELAD/Radiation
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. GELAD/Radiation
    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
    name
    GELAD
    other Names
    1. Gemcitabine, Etoposide, Dexamethasone, Pegaspargase
    type
    DRUG
  2. arm Group Labels
    1. GELAD/Radiation
    description
    Radiotherapy: 50-56Gy
    name
    Radiotherapy
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
52
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
    measure
    Complete response rate
    time Frame
    28 days after 4 cycles of chemotherapy
secondary Outcomes
  1. description
    Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
    measure
    Progression free survival
    time Frame
    2-year
  2. description
    The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
    measure
    Overall Response rate
    time Frame
    28 days after 4 cycles of chemotherapy
  3. description
    Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
    measure
    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
  4. description
    Overall survival is defiend as the time from entry onto the treatment until death of any reason
    measure
    Overall survival
    time Frame
    2-year
Full 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.
Source references
references
  1. 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.
    pmid
    34806163
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
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        9&amp;version=HealthProfessional&amp;language=English'); return(false);">Level of evidence C3</a>]</p></li><li> A retrospective study (<a href="/clinicaltrials/NCT02733458">NCT02733458</a>) included 35 patients with newly diagnosed stage III to IV, relapsed, or refractory ENKL. Patients received P-GEMOX.[<a href="#cit/section_8.1
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        =HealthProfessional&amp;language=English'); return(false);">Level of evidence C3</a>]</p></li><li> A retrospective study (<a href="/clinicaltrials/NCT02733458">NCT02733458</a>) included 35 patients with newly diagnosed stage III to IV, relapsed, or refractory ENKL. Patients received P-GEMOX.[<a href="#cit/section_8.10">10</a>]<di
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        rofessional&amp;language=English'); return(false);">Level of evidence C3</a>]</li></ul></div></li><li>A prospective multicenter study (<a href="/clinicaltrials/NCT02733458">NCT02733458</a>) included 52 patients with newly diagnosed stage IE/IIE ENKL who received two cycles of GELAD followed by intensity-modulated radiotherapy (50
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        mp;language=English'); return(false);">Level of evidence C3</a>]</li></ul></div></li><li>A prospective multicenter study (<a href="/clinicaltrials/NCT02733458">NCT02733458</a>) included 52 patients with newly diagnosed stage IE/IIE ENKL who received two cycles of GELAD followed by intensity-modulated radiotherapy (50&#8211;56 Gy
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      source retrieved at
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      source title
      Peripheral T-Cell Non-Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 13, 2025
        datetime
        2025-05-13T12:00:00Z
        display
        May 13, 2025

    Preserved source evidence · Independent clinical review pending · Not medical advice