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Mild-dose IMRT for Early-staged Extranodal Nasal-type NK/T-cell Lymphoma With CR Tumor After GELOX Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229682
Recruitment Status : Unknown
Verified September 2014 by Yujing ZHANG, MD/PhD, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2014
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):
Yujing ZHANG, MD/PhD, Sun Yat-sen University

Brief Summary:
This study is to make sure whether reduced-dose radiation treatment is sufficient to control the disease in patients with early-staged extranodal nasal-type NK/T-cell lymphoma, who have got complete remission tumor after chemotherapy in a new and more effective asparaginase-based GELOX regimen

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Lymphoma, Extranodal NK/T-cell Lymphoma,Nasal-type, Radiation: Mild-dose IMRT Phase 2

Detailed Description:

Definitive radiotherapy(RT) is mainstay in combined-modality treatment for patients with early-staged extranodal nasal-type NK/T-cell lymphoma(ENKTL),it can be used upfront or after short courses of chemotherapy. The typical dose of RT is recommended as 50-56Gy in conventional fractionations with 3 dimensional conformal RT or intensity-modulated radiation treatment(IMRT). Asparaginase-based chemotherapy regimens are being investigated, and primary results showed superior to previous anthracycline-based (eg. CHOP) chemotherapy. GELOX is a new asparaginase-based chemotherapy regimen designed and published in our institute, and the rate of complete remission(CR) is well improved. We hypothesis the reduced-dose radiation treatment(IMRT in 46Gy) is sufficient to control the disease in patients with early-staged ENKTL, who have got CR after GELOX chemotherapy, and to validate in this phase II study.

  1. Patients:

    • All patients should sign a written informed consent form before enrollment, and the study should be approved by the Sun Yat-sen University Cancer Center Ethics Board.
    • Baseline of patients: Computed tomography (CT) scans of the chest, abdomen, and pelvis, magnetic resonance imaging studies of the head and neck, and bilateral bone marrow aspiration or biopsy. Positron emission tomography-CT scans (optional). Epstein-Barr virus (EBV) DNA blood levels, titer of EBV antibody (EA-IgA, VCA-IgA).
    • Recheck before and after GELOX chemotherapy and IMRT: Epstein-Barr virus (EBV) DNA blood levels, titer of EBV antibody (EA-IgA, VCA-IgA), computed tomography (CT) scans of the chest, abdomen, and pelvis, magnetic resonance imaging studies of the head and neck, positron emission tomography-CT scans (optional).
  2. Treatment Protocol:

    1. The GELOX regimen consist of the following drugs: gemcitabine:1250 mg/ m2 on days 1,iv drip; oxaliplatin:85 mg/m2 on day 1, iv drip; pegaspargase: 2500 IU/m 2 daily on day 1,intramuscular. The treatment cycle is repeated every 14 days.
    2. IMRT is delivered using 6-8MeV linear accelerator using extended involved-field intensity-modulated radiation treatment planning. The RT dose is 46.2 grays (Gy) in 22 fractions, and a simultaneous-boost method is used.

      • We assign gross tumor volume (GTV) to 46.2Gy/22F, which is delineated according to the initial gross tumor volume identified with imaging and physical examination, including the primary tumor and involved regional lymph nodes.
      • The high-risk clinical target volume (CTV1) is assigned to 41.8Gy/22F, which is delineated including the first batch of adjacent structures around GTV, and lymph node group apt for involvement according to clinical feature of individual tumors.
      • The low-risk clinical target volume (CTV2) is assigned to 36.3Gy/22F, which is delineated including the extrapolated structures outside of CTV1 sites, and LN groups adjacent to CTV1 LN groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mild-dose Intensity-modulated Radiation Treatment for Stage IE/IIE Extranodal Nasal-type NK/T-cell Lymphoma With Complete Remission Tumor After Combination of Gemcitabine, Oxaliplatin, and Asparaginase (GELOX) Chemotherapy:a Phase II Study
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Mild-dose IMRT

Experimental: Mild-dose of 46Gy with IMRT

Drug:

gemcitabine:1250mg/m2 (iv drip) on days 1, oxaliplatin: 85 mg/m2 (iv drip) on day 1, and pegaspargase: 2500 IU/m2 (intramuscular injection) on day 1. Cycle is repeated every 14 days

IMRT: IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 46.2 grays (Gy) in 22 fractions.

Radiation: Mild-dose IMRT
IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 46.2 grays (Gy) in 22 fractions.
Other Name: Mild-dose intensity-modulated radiation treatment




Primary Outcome Measures :
  1. loco-regional tumor control [ Time Frame: every 3 months after IMRT for 2 years, and then every 6 months for the next 3 years. ]
    loco-regional tumor control was examined with physical examination and image methods.


Secondary Outcome Measures :
  1. progression-free survival(PFS) [ Time Frame: every 3 months after IMRT for 2 years, and then every 6 months for the next 3 years ]
    progression-free survival(PFS): time from the date of enrollment to date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first

  2. overall survival(OS) [ Time Frame: every 3 months after IMRT for 2 years, and then every 6 months for the next 3 years ]
    overall survival (OS): time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly diagnosed ENKTL
  • age:18-75years
  • Ann Arbor stage IE,or stage IIE with cervical lymph node involvement
  • at lease one measurable lesion
  • received GELOX chemotherapy and got CR before radiotherapy
  • Eastern CooperativeOncology Group performance status of 0 to 2
  • Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion Criteria:

  • mismatch the inclusion criteria,
  • got non-CR after GELOX chemotherapy before IMRT,
  • systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol,
  • primary lesion not from the upper aerodigestive tract

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229682


Contacts
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Contact: Yujing ZHANG, MD/PHD 86-20-87343702 zhangyj@sysucc.org.cn

Locations
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China, Guangdong
Dept. Radiation Oncology, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Contact: Yujing Zhang, MD/PhD    86-20-87343702    zhangyj@sysucc.org.cn   
Principal Investigator: Yujing Zhang, MD/PhD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yujing Zhang, MD/PhD Sun Yat-sen University

Publications:
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Responsible Party: Yujing ZHANG, MD/PhD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02229682    
Other Study ID Numbers: SYSUCC-NKTRT-01
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014
Keywords provided by Yujing ZHANG, MD/PhD, Sun Yat-sen University:
extranodal NK/T-cell lymphoma,nasal-type,
radiotherapy,
intensity-modulated radiation treatment,
asparaginase-based chemotherapy,
loco-regional control,
survival
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Asparaginase
Antineoplastic Agents