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Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Conventional chemotherapy
Maintenance chemotherapy 1
Maintenance chemotherapy 2
Sponsored by
Shanghai Proton and Heavy Ion Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring maintenance chemotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 and ≤ 70 years
  • Histologically confirmed nasopharyngeal carcinoma, WHO (World Health Organization) classification II/III
  • With distant metastasis
  • With measurable lesions that can be detected by imaging studies
  • Achieving PR (partial response) after 4 cycles of conventional chemotherapy
  • Life expectancy ≥ 6 months
  • ECOG (Eastern Cooperative Oncology Group): 0-1, no significant active concurrent medical illnesses
  • Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N > 2000/mm^3; PLT (platelet count) > 100,000/mm^3; total bilirubin < 1.5mg/dl; AST (aspartate aminotransferase)/ALT (alanine aminotransferase) < 1.5 ULN (upper limit of normal); SCr (serum creatinine) < 1.5mg/dl; CCR (creatinine clearance rate) > 60ml/min
  • Willing to accept adequate contraception for women with childbearing potential
  • Ability to understand character and individual consequences of the clinical trial
  • Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

  • Received previous treatment for metastatic disease
  • Pregnant or lactating women
  • A diagnosis of malignancy other than CIS (carcinoma in situ) of the cervix, BCC (basal cell carcinoma) and SCC (squamous cell carcinoma) of the skin within the past 5 years
  • Refusal of the patient to participate into the study

Sites / Locations

  • Peking University Cancer HospitalRecruiting
  • The First Affiliated Hospital of Fujian Medical UniversityRecruiting
  • The First Affiliated Hospital of Xiamen UniversityRecruiting
  • Cancer Hospital of Guangxi Medical UniversityRecruiting
  • The People's Hospital of Guangxi Zhuang Autonomous RegionRecruiting
  • Tongji Hospital, Tongji Medical College of HUSTRecruiting
  • Jiangxi Province Tumor HospitalRecruiting
  • Jiangxi Provincial Cancer HospitalRecruiting
  • Fudan University Shanghai Cancer centerRecruiting
  • Shanghai Proton and Heavy Ion CenterRecruiting
  • Eye & ENT Hospital of Fudan UniversityRecruiting
  • West China HospitalRecruiting
  • National Cancer Centre, SingaporeRecruiting
  • Taichung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional chemotherapy

Maintenance chemotherapy 1

Maintenance chemotherapy 2

Arm Description

Patients in this arm will only receive 4-8 cycles of cisplatin-based regimen. TPF ( docetaxel, cisplatin and 5-fluorouracil ), TP (docetaxel and cisplatin), GP (gemcitabine and cisplatin) and PF (cisplatin and 5-fluorouracil) regimens are preferred.

Patients in this arm will receive 6 cycles of oral fluoropyrimidine monotherapy as maintenance therapy, in addition to 4-8 cycles of cisplatin-based standard chemotherapy.

Patients in this arm will receive oral fluoropyrimidine maintenance therapy until disease progression or intolerable toxicities, after 4-8 cycles of cisplatin-based standard chemotherapy.

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Full Information

First Posted
October 24, 2016
Last Updated
October 26, 2016
Sponsor
Shanghai Proton and Heavy Ion Center
Collaborators
Fudan University, Eye & ENT Hospital of Fudan University, The First Affiliated Hospital of Xiamen University, Jiangxi Provincial Cancer Hospital, Taichung Veterans General Hospital, First Affiliated Hospital of Fujian Medical University, Cancer Hospital of Guangxi Medical University, National Cancer Centre, Singapore, West China Hospital, Peking University Cancer Hospital & Institute, Tongji Hospital, People's Hospital of Guangxi
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1. Study Identification

Unique Protocol Identification Number
NCT02944708
Brief Title
Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
Official Title
A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center
Collaborators
Fudan University, Eye & ENT Hospital of Fudan University, The First Affiliated Hospital of Xiamen University, Jiangxi Provincial Cancer Hospital, Taichung Veterans General Hospital, First Affiliated Hospital of Fujian Medical University, Cancer Hospital of Guangxi Medical University, National Cancer Centre, Singapore, West China Hospital, Peking University Cancer Hospital & Institute, Tongji Hospital, People's Hospital of Guangxi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms. Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities.
Detailed Description
This is a phase 3 randomized clinical trial to determine the efficacy of maintenance chemotherapy for the treatment of metastatic chemotherapy and how it should be delivered. Participants will be randomized to 3 arms. Arm 1 (control group), participants will receive only conventional chemotherapy; arm 2 (experimental group), participants will receive up to 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3 (experimental group), after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities. Participants in all 3 arms will receive similar conventional chemotherapy. Four to eight cycles of conventional chemotherapy with platinum-based regimen is preferred. Maintenance chemotherapy should use one of the regimens: S1 (40mg, twice a day for 14 days, every 3 weeks), capecitabine (1000mg/m^2, twice a day for 14 days, every 3 weeks) or Tegafur-uracil (100mg/m^2, q8h, for 14 days, every 3 weeks). The response of treatment will be evaluated according to RECIST criteria. Adverse events will be documented according to CTCAE v4.03.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
maintenance chemotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Conventional chemotherapy
Arm Type
Active Comparator
Arm Description
Patients in this arm will only receive 4-8 cycles of cisplatin-based regimen. TPF ( docetaxel, cisplatin and 5-fluorouracil ), TP (docetaxel and cisplatin), GP (gemcitabine and cisplatin) and PF (cisplatin and 5-fluorouracil) regimens are preferred.
Arm Title
Maintenance chemotherapy 1
Arm Type
Experimental
Arm Description
Patients in this arm will receive 6 cycles of oral fluoropyrimidine monotherapy as maintenance therapy, in addition to 4-8 cycles of cisplatin-based standard chemotherapy.
Arm Title
Maintenance chemotherapy 2
Arm Type
Experimental
Arm Description
Patients in this arm will receive oral fluoropyrimidine maintenance therapy until disease progression or intolerable toxicities, after 4-8 cycles of cisplatin-based standard chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Conventional chemotherapy
Intervention Type
Drug
Intervention Name(s)
Maintenance chemotherapy 1
Intervention Type
Drug
Intervention Name(s)
Maintenance chemotherapy 2
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
From the time point the patients are included in the study, median of 3 years.
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
From the time point the patients are included in the study, median of 3 years.
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time Frame
From the time point the patients are included in the study, median of 3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 and ≤ 70 years Histologically confirmed nasopharyngeal carcinoma, WHO (World Health Organization) classification II/III With distant metastasis With measurable lesions that can be detected by imaging studies Achieving PR (partial response) after 4 cycles of conventional chemotherapy Life expectancy ≥ 6 months ECOG (Eastern Cooperative Oncology Group): 0-1, no significant active concurrent medical illnesses Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N > 2000/mm^3; PLT (platelet count) > 100,000/mm^3; total bilirubin < 1.5mg/dl; AST (aspartate aminotransferase)/ALT (alanine aminotransferase) < 1.5 ULN (upper limit of normal); SCr (serum creatinine) < 1.5mg/dl; CCR (creatinine clearance rate) > 60ml/min Willing to accept adequate contraception for women with childbearing potential Ability to understand character and individual consequences of the clinical trial Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial Exclusion Criteria: Received previous treatment for metastatic disease Pregnant or lactating women A diagnosis of malignancy other than CIS (carcinoma in situ) of the cervix, BCC (basal cell carcinoma) and SCC (squamous cell carcinoma) of the skin within the past 5 years Refusal of the patient to participate into the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Kong, MD
Email
lin.kong@sphic.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiyi Hu, MD
Email
jiyi.hu@sphic.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiade J Lu, MD
Organizational Affiliation
Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Sun, MD
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinshen Hong, MD
Email
hjs703@126.com
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Lin, MD
Email
linqin05@163.com
Facility Name
Cancer Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Zhu, MD
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heming Lu, MD
Facility Name
Tongji Hospital, Tongji Medical College of HUST
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoqing Hu, MD
Facility Name
Jiangxi Province Tumor Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaochang Gong, MD
Email
gxcanddw@163.com
Facility Name
Jiangxi Provincial Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaochang Gong, MD
Email
gxcanddw@163.com
Facility Name
Fudan University Shanghai Cancer center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201315
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaosu Hu, MD
Email
hucsu62@yahoo.com
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201315
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Kong, MD
Email
lin.kong@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Jiyi Hu, MD
Email
jiyi.hu@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Jiade J Lu, MD
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengzi Wang, MD
Email
shengziwang@fudan.edu.cn
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Li, MD
Facility Name
National Cancer Centre, Singapore
City
Singapore
ZIP/Postal Code
119082
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boon Cher Goh, MD
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Ching Lin, MD
Email
jclin@vghtc.gov.tw

12. IPD Sharing Statement

Learn more about this trial

Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma

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