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

September 28, 2014 updated by: Yujing ZHANG, MD/PhD, Sun Yat-sen University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Dept. Radiation Oncology, Sun Yat-sen University Cancer Center

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Mild-dose intensity-modulated radiation treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 3 months after IMRT for 2 years, and then every 6 months for the next 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every 3 months after IMRT for 2 years, and then every 6 months for the next 3 years
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.
every 3 months after IMRT for 2 years, and then every 6 months for the next 3 years

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Yujing Zhang, MD/PhD, Sun Yat-sen University

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

October 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 1, 2014

Study Record Updates

Last Update Posted (Estimate)

September 30, 2014

Last Update Submitted That Met QC Criteria

September 28, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-NKTRT-01

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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