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Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Neoplasms

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
gemcitabine and cisplatin
5-Fluorouracil and cisplatin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Neoplasms focused on measuring Advanced Nasopharyngeal Carcinoma, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

gemcitabine and cisplatin

5-Fluorouracil and cisplatin

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival (OS)
Objective response rate (ORR)
Number of Participants with Adverse Events

Full Information

First Posted
January 31, 2012
Last Updated
September 27, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01528618
Brief Title
Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma
Official Title
A Randomized, Multicenter Phase III Clinical Trial Comparing Gemcitabine and Cisplatin With 5-Fluorouracil and Cisplatin in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 21, 2012 (Actual)
Primary Completion Date
April 10, 2016 (Actual)
Study Completion Date
December 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in southern and southeastern China ,where the incidence rate has been documented between 10 and 150 cases per 100,000 population per year. NPC is a radiosensitive tumor, and radiotherapy is considered to be the treatment of choice for most cases. The 5-year survival rate (all stages) is around 50% .In other words, more than half of the NPC cases will eventually fail radiotherapy and reasons of the failure are both local relapse and remote metastasis. For these advanced or metastatic NPC, chemotherapy is the most important therapeutics,and they are relatively responsive to chemotherapy compared to other head and neck cancers. The backbone of the treatment for recurrent/metastatic (R/M) NPC is cisplatin containing regimen, which is also regarded as the standard regimen for other squamous cell carcinoma of head and neck (SCCHN). The FP regimen is widely used in R/M NPC patients now and its response rate is around 40%-65%,but the response period is usually short and the adverse reaction is frequent and badly tolerant, which influent the treatment compliance seriously. What's more, the catheters and pumps are necessary for continuous infusion of 5-Fluorouracil, which add to the cost, immobility and inconvenience of the treatment. Preclinical and clinical data show synergistic activity between gemcitabine and cisplatin without overlapping toxicity. Several clinical trials enrolling a minority of advanced NPC patients suggest GP regimen has promising effectiveness and well tolerated side effects, and they indicated a potential possibility that the GP regimen comes to the standard first line choice instead of the FP regimen

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Neoplasms
Keywords
Advanced Nasopharyngeal Carcinoma, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gemcitabine and cisplatin
Arm Type
Experimental
Arm Description
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.
Arm Title
5-Fluorouracil and cisplatin
Arm Type
Active Comparator
Arm Description
5-Fluorouracil 4,000 mg/m2 CIV over 96 hours and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
gemcitabine and cisplatin
Other Intervention Name(s)
GP
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil and cisplatin
Other Intervention Name(s)
FP
Intervention Description
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)
Primary Outcome Measure Information:
Title
Progression free survival (PFS) assessed by independent image committee and the investigators
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
36 months
Title
Objective response rate (ORR)
Time Frame
36 months
Title
Number of Participants with Adverse Events
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li zhang, doctor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Oncology,Cancer Center of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34379443
Citation
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.
Results Reference
derived
PubMed Identifier
27567279
Citation
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. Erratum In: Lancet. 2016 Oct 15;388(10054):1882.
Results Reference
derived

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Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma

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