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

NCT02229682 | Unknown Phase 2 DMC

• 1 other identifier: SYSUCC-NKTRT-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphoma,; Non-Hodgkin Lymphoma,; Extranodal NK/T-cell Lymphoma,Nasal-type,

Keywords

extranodal NK/T-cell lymphoma,nasal-type,; radiotherapy,; intensity-modulated radiation treatment,; asparaginase-based chemotherapy,; loco-regional control,; survival

Outcome Measures

Primary Outcomes (1)

• loco-regional tumor control

  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 Outcomes (2)

• progression-free survival(PFS)

  every 3 months after IMRT for 2 years, and then every 6 months for the next 3 years

• overall survival(OS)

  every 3 months after IMRT for 2 years, and then every 6 months for the next 3 years

Study Arms (1)

Mild-dose IMRT

EXPERIMENTAL

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

Interventions

Mild-dose IMRT RADIATION

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.

Also known as: Mild-dose intensity-modulated radiation treatment

Mild-dose IMRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Dept. Radiation Oncology, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

• 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.

  PMID: 22811078 BACKGROUND

• Gregoire 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.

  PMID: 24183870 BACKGROUND

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell

Study Officials

• Yujing Zhang, MD/PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujing ZHANG, MD/PHD

CONTACT

86-20-87343702; zhangyj@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 1, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2019
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

CN (1)