Mild-dose IMRT for Early-staged Extranodal Nasal-type NK/T-cell Lymphoma With CR Tumor After GELOX Chemotherapy
Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma,; Non-Hodgkin Lymphoma,; Extranodal NK/T-cell Lymphoma,Nasal-type,
Intervention: Mild-dose IMRT (Radiation)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Sun Yat-sen University Official(s) and/or principal investigator(s): Yujing Zhang, MD/PhD, Principal Investigator, Affiliation: Sun Yat-sen University
Overall contact: Yujing ZHANG, MD/PHD, Phone: 86-20-87343702, Email: zhangyj@sysucc.org.cn
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
Clinical Details
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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: loco-regional tumor control
Secondary outcome: progression-free survival(PFS)overall survival(OS)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Yujing ZHANG, MD/PHD, Phone: 86-20-87343702, Email: zhangyj@sysucc.org.cn
Dept. Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong 510060, China; Not yet recruiting Yujing Zhang, MD/PhD, Phone: 86-20-87343702, Email: zhangyj@sysucc.org.cn Yujing Zhang, MD/PhD, Principal Investigator
Additional Information
Related publications: Wang L, Wang ZH, Chen XQ, Li YJ, Wang KF, Xia YF, Xia ZJ. First-line combination of gemcitabine, oxaliplatin, and L-asparaginase (GELOX) followed by involved-field radiation therapy for patients with stage IE/IIE extranodal natural killer/T-cell lymphoma. Cancer. 2013 Jan 15;119(2):348-55. doi: 10.1002/cncr.27752. Epub 2012 Jul 18. Grégoire V, Ang K, Budach W, Grau C, Hamoir M, Langendijk JA, Lee A, Le QT, Maingon P, Nutting C, O'Sullivan B, Porceddu SV, Lengele B. Delineation of the neck node levels for head and neck tumors: a 2013 update. DAHANCA, EORTC, HKNPCSG, NCIC CTG, NCRI, RTOG, TROG consensus guidelines. Radiother Oncol. 2014 Jan;110(1):172-81. doi: 10.1016/j.radonc.2013.10.010. Epub 2013 Oct 31.
Starting date: October 2014
Last updated: September 28, 2014
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