Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
NCT ID: NCT02944708
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
384 participants
INTERVENTIONAL
2015-10-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Conventional chemotherapy
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.
Conventional chemotherapy
Maintenance chemotherapy 1
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.
Conventional chemotherapy
Maintenance chemotherapy 2
Interventions
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Conventional chemotherapy
Maintenance chemotherapy 1
Maintenance chemotherapy 2
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Fudan University
OTHER
Eye & ENT Hospital of Fudan University
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Jiangxi Provincial Cancer Hospital
OTHER
Taichung Veterans General Hospital
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Cancer Hospital of Guangxi Medical University
OTHER
National Cancer Centre, Singapore
OTHER
West China Hospital
OTHER
Peking University Cancer Hospital & Institute
OTHER
Tongji Hospital
OTHER
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
Shanghai Proton and Heavy Ion Center
OTHER
Responsible Party
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Lin Kong
Consultant doctor, chair of head and neck cancer
Principal Investigators
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Jiade J Lu, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
Locations
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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China
Jiangxi Province Tumor Hospital
Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, China
Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality, China
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital
Chengdu, Sichuan, China
National Cancer Centre, Singapore
Singapore, , Singapore
Taichung Veterans General Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Yan Sun, MD
Role: primary
Jinshen Hong, MD
Role: primary
Qin Lin, MD
Role: primary
Xiaodong Zhu, MD
Role: primary
Heming Lu, MD
Role: primary
Guoqing Hu, MD
Role: primary
Xiaochang Gong, MD
Role: primary
Xiaochang Gong, MD
Role: primary
Chaosu Hu, MD
Role: primary
Lin Kong, MD
Role: primary
Jiyi Hu, MD
Role: backup
Shengzi Wang, MD
Role: primary
Ping Li, MD
Role: primary
Boon Cher Goh, MD
Role: primary
Jin-Ching Lin, MD
Role: primary
Other Identifiers
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SPHIC-TR-HNCNS-2015-04
Identifier Type: -
Identifier Source: org_study_id