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Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02944708
Recruitment Status : Unknown
Verified October 2016 by Lin Kong, Shanghai Proton and Heavy Ion Center.
Recruitment status was:  Recruiting
First Posted : October 26, 2016
Last Update Posted : October 27, 2016
Sponsor:
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
Beijing Cancer Hospital
Tongji Hospital
People's Hospital of Guangxi
Information provided by (Responsible Party):
Lin Kong, Shanghai Proton and Heavy Ion Center

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Conventional chemotherapy Drug: Maintenance chemotherapy 1 Drug: Maintenance chemotherapy 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
Study Start Date : October 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional chemotherapy
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.
Drug: Conventional chemotherapy
Experimental: Maintenance chemotherapy 1
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.
Drug: Conventional chemotherapy
Drug: Maintenance chemotherapy 1
Experimental: Maintenance chemotherapy 2
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.
Drug: Conventional chemotherapy
Drug: Maintenance chemotherapy 2



Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: From the time point the patients are included in the study, median of 3 years. ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From the time point the patients are included in the study, median of 3 years. ]
  2. 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944708


Contacts
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Contact: Lin Kong, MD lin.kong@sphic.org.cn
Contact: Jiyi Hu, MD jiyi.hu@sphic.org.cn

Locations
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China, Beijing
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Yan Sun, MD         
China, Fujian
The First Affiliated Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350005
Contact: Jinshen Hong, MD       hjs703@126.com   
The First Affiliated Hospital of Xiamen University Recruiting
Xiamen, Fujian, China, 361003
Contact: Qin Lin, MD       linqin05@163.com   
China, Guangxi
Cancer Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China, 530021
Contact: Xiaodong Zhu, MD         
The People's Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China, 530021
Contact: Heming Lu, MD         
China, Hubei
Tongji Hospital, Tongji Medical College of HUST Recruiting
Wuhan, Hubei, China, 430030
Contact: Guoqing Hu, MD         
China, Jiangxi
Jiangxi Province Tumor Hospital Recruiting
Nanchang, Jiangxi, China, 330029
Contact: Xiaochang Gong, MD       gxcanddw@163.com   
Jiangxi Provincial Cancer Hospital Recruiting
Nanchang, Jiangxi, China, 330029
Contact: Xiaochang Gong, MD       gxcanddw@163.com   
China, Shanghai
Fudan University Shanghai Cancer center Recruiting
Shanghai, Shanghai, China, 201315
Contact: Chaosu Hu, MD       hucsu62@yahoo.com   
Shanghai Proton and Heavy Ion Center Recruiting
Shanghai, Shanghai, China, 201315
Contact: Lin Kong, MD       lin.kong@sphic.org.cn   
Contact: Jiyi Hu, MD       jiyi.hu@sphic.org.cn   
Principal Investigator: Jiade J Lu, MD         
Eye & ENT Hospital of Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Shengzi Wang, MD       shengziwang@fudan.edu.cn   
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Ping Li, MD         
Singapore
National Cancer Centre, Singapore Recruiting
Singapore, Singapore, 119082
Contact: Boon Cher Goh, MD         
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Jin-Ching Lin, MD       jclin@vghtc.gov.tw   
Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
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
Beijing Cancer Hospital
Tongji Hospital
People's Hospital of Guangxi
Investigators
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Principal Investigator: Jiade J Lu, MD Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
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Responsible Party: Lin Kong, Consultant doctor, chair of head and neck cancer, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier: NCT02944708    
Other Study ID Numbers: SPHIC-TR-HNCNS-2015-04
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Keywords provided by Lin Kong, Shanghai Proton and Heavy Ion Center:
maintenance chemotherapy
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases