Extranodal NK/T-cell Lymphoma,Nasal-type, Clinical Trial
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
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
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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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment