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NCT Number: NCT02733458

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

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.

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Key information

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Hematology, Renji Hospital, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GELAD

Drug

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

Radiotherapy

Radiation

Radiotherapy: 50-56Gy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. Overall survival

    Time frame: 2-year

    Overall survival is defiend as the time from entry onto the treatment until death of any reason

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 11, 2016
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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