Efficacy and Safety Study of P-Gemox vs.EPOCH as First-line Chemotherapy to Treat NK/T-cell Lymphoma With Early Stage

NCT02359162 | Terminated Phase 3 DMC

• 1 other identifier: SYSUCC-NK-308
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose :To compare the efficacy and and safety of the P-Gemox chemotherapy regimen with those of the EPOCH regimen for stage IE to IIE ENKTL.

Conditions

Lymphoma, Extranodal NK-T-Cell

Keywords

NK/T-cell lymphoma; induction chemotherapy; survival

Outcome Measures

Primary Outcomes (1)

• progression free survival

  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

  up to end of follow-up-phase (approximately 3 years)

Secondary Outcomes (3)

• complete remission rate

  every 4 weeks,up to completion of treatment(approximately 6 months)

• overall survival

  .up to end of follow-up-phase (approximately 3 years)

• safety, as measured by adverse events

  up to end of follow-up-phase (approximately 3 years)

Other Outcomes (4)

• serum Epstein-Barr virus(EBV) DNA copies

  every 3 weeks,up to completion of treatment(approximately 6 months)

• serum β2-microglobulin

  every 3 weeks,up to completion of treatment(approximately 6 months)

• serum interleukin 9

  every 3 weeks,up to completion of treatment(approximately 6 months)

Study Arms (2)

P-Gemox

EXPERIMENTAL

P-Gemox:gemcitabine :1250mg/m2 (ivdrip) on days 1, oxaliplatin :85 mg/m2 (ivdrip) 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 50 grays (Gy) in 25 fractions.

Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Pegaspargase; Radiation: IMRT

EPOCH

ACTIVE COMPARATOR

EPOCH:Patients received the EPOCH chemotherapy regimen every 3 weeks. The EPOCH regimen included a 24 h continuous infusion of etoposide (50 mg/m 2 /day), vincristine (0.4 mg/m 2 /day) and doxorubicin(10 mg/m 2 /day administered on days 1-4, followed by cyclophosphamide (750 mg/m2 /day) over 15 min intravenously on day 5 and prednisone (60 mg/m 2 /day) on days1- 5 orally. IMRT：IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50 grays (Gy) in 25 fractions.

Drug: Etoposide; Drug: Vincristine; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Prednisone; Radiation: IMRT

Interventions

Gemcitabine DRUG

gemcitabine :1250mg/m2 (ivdrip) on days 1

P-Gemox

Oxaliplatin DRUG

oxaliplatin :85 mg/m2 (ivdrip) on day 1

P-Gemox

Pegaspargase DRUG

pegaspargase : 2500 IU/m2 (intramuscular injection)

P-Gemox

Etoposide DRUG

50 mg/m 2 /day 24 h continuous infusion on days 1-4

EPOCH

Vincristine DRUG

0.4 mg/m 2 /day 24 h continuous infusion on days 1-4

EPOCH

Doxorubicin DRUG

10 mg/m 2 /day 24 h continuous infusion on days 1-4

EPOCH

Cyclophosphamide DRUG

cyclophosphamide 750 mg/m2 /day over 15 min intravenously on day 5

EPOCH

Prednisone DRUG

60 mg/m 2 /day 60 mg/m 2 /day on days 1-5

EPOCH

IMRT RADIATION

IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50 grays (Gy) in 25 fractions.

Also known as: Intensity-modulated radiation therapy

EPOCH; P-Gemox

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed ENKTL
• age:18-69years
• Ann Arbor stage IE,or stage IIE with cervical lymph node involvement
• at lease one measurable lesion
• receive no chemotherapy or radiotherapy before
• 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:

• 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 respiratory

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (3)

• Wang H, Wuxiao ZJ, Zhu J, Wang Z, Wang KF, Li S, Chen X, Lu Y, Xia ZJ. Comparison of gemcitabine, oxaliplatin and L-asparaginase and etoposide, vincristine, doxorubicin, cyclophosphamide and prednisone as first-line chemotherapy in patients with stage IE to IIE extranodal natural killer/T-cell lymphoma: a multicenter retrospective study. Leuk Lymphoma. 2015 Apr;56(4):971-7. doi: 10.3109/10428194.2014.939964. Epub 2014 Aug 20.

  PMID: 24991715 RESULT

• 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 RESULT

• Huang H, Lin Z, Lin X, Cai Q, Xia Z, Jiang W. Long-term outcomes of patients with newly diagnosed extranodal natural killer/T-cell lymphoma treated by etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin regimen: a single-institution experience. Leuk Lymphoma. 2011 Jun;52(6):1041-8. doi: 10.3109/10428194.2011.561388.

  PMID: 21599590 RESULT

Related Links

• medlineplus
• drug imformation

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Gemcitabine; Oxaliplatin; pegaspargase; Etoposide; Vincristine; Doxorubicin; Cyclophosphamide; Prednisone; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Hua Wang, MD.

  Department of Hematological Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of departments of Department of Hematological Oncology, Sun Yat-sen University Cancer Center.

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 9, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 9, 2018

Record last verified: 2017-10

Locations

CN (1)