NCT01528618

Brief Summary

The present study will be a randomized, control, multicenter phase III study of recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC) treated with Gemcitabine (Gemzar, Lilly) and cisplatin regimen (GP) or 5-Fluorouracil plus cisplatin regimen (FP). The population consists of recurrent or metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be evaluated according to Standard WHO response criteria and NCI-CTC AE V3.0.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

February 21, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2016

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

4.1 years

First QC Date

January 31, 2012

Last Update Submit

September 27, 2021

Conditions

Nasopharyngeal Neoplasms

Keywords

Advanced Nasopharyngeal Carcinomatreatment

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS) assessed by independent image committee and the investigators

    36 months

Secondary Outcomes (3)

  • Overall survival (OS)

    36 months

  • Objective response rate (ORR)

    36 months

  • Number of Participants with Adverse Events

    36 months

Study Arms (2)

gemcitabine and cisplatin

EXPERIMENTAL

gemcitabine 1,000 mg/m2 over 30 to 60 minutes on days 1, 8, and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.

Drug: gemcitabine and cisplatin

5-Fluorouracil and cisplatin

ACTIVE COMPARATOR

5-Fluorouracil 4,000 mg/m2 CIV over 96 hours and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.

Drug: 5-Fluorouracil and cisplatin

Interventions

gemcitabine and cisplatinDRUG

The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1 only

Also known as: GP
gemcitabine and cisplatin
5-Fluorouracil and cisplatinDRUG

The FP regimen consists of 5-Fluorouracil 1,000 mg/m2/day which was administered as a continuous intravenous infusion for 96 hours after completion of the cisplatin on days 1( 80 mg/m2 i.v. infusion for 4 h)

Also known as: FP
5-Fluorouracil and cisplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven NPC diagnosis
  • Elder than 18 years old are inclusive
  • Recurrence or metastatic nasopharyngeal carcinoma with evidence of unsuitable for local treatment
  • Amenable to regular follow-up
  • Subjects with at least one measurable lesion (Tumor lesions that are situated in a previously irradiated area could not be considered measurable).
  • Performance status: 0-1(ECOG)
  • WBC \> 4.0X109/L, PLT \> 100X109/L, with normal hepatic function(AST, ALT \< 2.5 x upper limit of normal , and bilirubin \< 1.5 x upper limit of normal), with normal renal function (Creatinine \< 1.5 x upper limit of normal)
  • No chemotherapy or radical radiotherapy received within 6 months prior to enrollment
  • Life expectancy over twelve weeks
  • Signed and dated informed consent before the start of specific protocol procedures
  • Ability to comply with trial requirements.

You may not qualify if:

  • Patient suitable for local treatment (eg. radiotherapy)
  • Active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
  • Patient with central nervous system metastasis
  • Patient life threatening medical condition
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
  • Performance status ≥ 2
  • With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI CTC\] grade ≥ 2)
  • Serious concurrent illness
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors\[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry.
  • Patient refusing participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Oncology,Cancer Center of Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

  • Hong S, Zhang Y, Yu G, Peng P, Peng J, Jia J, Wu X, Huang Y, Yang Y, Lin Q, Xi X, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C, Fang W, Zhang L. Gemcitabine Plus Cisplatin Versus Fluorouracil Plus Cisplatin as First-Line Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: Final Overall Survival Analysis of GEM20110714 Phase III Study. J Clin Oncol. 2021 Oct 10;39(29):3273-3282. doi: 10.1200/JCO.21.00396. Epub 2021 Aug 11.

    PMID: 34379443DERIVED

  • Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. doi: 10.1016/S0140-6736(16)31388-5. Epub 2016 Aug 23.

    PMID: 27567279DERIVED

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

GemcitabineCisplatinFluorouracil

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinones

Study Officials

  • li zhang, doctor

    Sun Yat-sen University

    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

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 8, 2012

Study Start

February 21, 2012

Primary Completion

April 10, 2016

Study Completion

December 20, 2020

Last Updated

October 4, 2021

Record last verified: 2021-09

Locations

CN(1)