Clinical trial NCT02135042: Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
Official title: Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
Conditions: Epstein-Barr Virus Infection
Stage II Nasopharyngeal Carcinoma
Stage III Nasopharyngeal Carcinoma
Stage IVA Nasopharyngeal Carcinoma
Stage IVB Nasopharyngeal Carcinoma
Summary: There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
Interventions:
description: Given IV
name: Cisplatin
other_name: Abiplatin
Blastolem
Briplatin
CDDP
Cis-diammine-dichloroplatinum
Cis-diamminedichloridoplatinum
Cis-diamminedichloro Platinum (II)
Cis-diamminedichloroplatinum
Cis-dichloroammine Platinum (II)
Cis-platinous Diamine Dichloride
Cis-platinum
Cis-platinum II
Cis-platinum II Diamine Dichloride
Cismaplat
Cisplatina
Cisplatinum
Cisplatyl
Citoplatino
Citosin
Cysplatyna
DDP
Lederplatin
Metaplatin
Neoplatin
Peyrone's Chloride
Peyrone's Salt
Placis
Plastistil
Platamine
Platiblastin
Platiblastin-S
Platinex
Platinol
Platinol- AQ
Platinol-AQ
Platinol-AQ VHA Plus
Platinoxan
Platinum
Platinum Diamminodichloride
Platiran
Platistin
Platosin
type: Drug
description: Undergo clinical observation
name: Clinical Observation
type: Other
description: Given IV
name: Fluorouracil
other_name: 5-FU
5-Fluoro-2,4(1H, 3H)-pyrimidinedione
5-Fluorouracil
5-Fluracil
AccuSite
Actino-Hermal
Adrucil
Arumel
Cytosafe
Efudex
Efurix
Fiverocil
Fluoro Uracil
Fluoroplex
Fluouracil
Flurablastin
Fluracedyl
Fluracil
Fluril
Fluroblastin
Flurox
Ribofluor
Ro 2-9757
Ro-2-9757
Timazin
type: Drug
description: Given IV
name: Gemcitabine Hydrochloride
other_name: Difluorodeoxycytidine Hydrochloride
Gemzar
LY-188011
dFdCyd
type: Drug
description: Undergo IMRT
name: Intensity-Modulated Radiation Therapy
other_name: IMRT
Intensity Modulated RT
Intensity-Modulated Radiotherapy
type: Radiation
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Given IV
name: Paclitaxel
other_name: Anzatax
Asotax
Bristaxol
Praxel
Taxol
Taxol Konzentrat
type: Drug
description: Ancillary studies
name: Quality-of-Life Assessment
other_name: Quality of Life Assessment
type: Other
Study arms:
design_group_description: Patients receive PF regimen comprising cisplatin IV over 60-120 minutes and fluorouracil IV over 96 hours continuously beginning at least 4 weeks after completion of IMRT. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
design_group_title: Arm I (chemoradiation, cisplatin, fluorouracil)
design_group_type: Active Comparator
design_group_description: Patients receive GT regimen comprising paclitaxel IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 at least 4 weeks after completion of IMRT. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
design_group_title: Arm II (chemoradiation, gemcitabine hydrochloride, paclitaxel)
design_group_type: Experimental
design_group_description: Patients receive PF regimen as in Arm I of Phase II.
design_group_title: Arm III (chemoradiation, cisplatin, fluorouracil)
design_group_type: Active Comparator
design_group_description: Patients undergo clinical observation.
design_group_title: Arm IV (chemoradiation, observation)
design_group_type: Experimental
Sponsor: NRG Oncology
Collaborators: National Cancer Institute
Drug name mappings:
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 紫杉醇
lang: CN
name: Paclitaxel
lang: EN
name: パクリタキセル
lang: JP
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP