Nasopharyngeal Carcinoma Clinical Trial
Official title:
A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
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.
Status | Recruiting |
Enrollment | 384 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Peking University Cancer Hospital | Beijing | Beijing |
China | West China Hospital | Chengdu | Sichuan |
China | The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian |
China | Jiangxi Province Tumor Hospital | Nanchang | Jiangxi |
China | Jiangxi Provincial Cancer Hospital | Nanchang | Jiangxi |
China | Cancer Hospital of Guangxi Medical University | Nanning | Guangxi |
China | The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi |
China | Eye & ENT Hospital of Fudan University | Shanghai | Shanghai |
China | Fudan University Shanghai Cancer center | Shanghai | Shanghai |
China | Shanghai Proton and Heavy Ion Center | Shanghai | Shanghai |
China | Tongji Hospital, Tongji Medical College of HUST | Wuhan | Hubei |
China | The First Affiliated Hospital of Xiamen University | Xiamen | Fujian |
Singapore | National Cancer Centre, Singapore | Singapore | |
Taiwan | Taichung Veterans General Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
Shanghai Proton and Heavy Ion Center | Beijing Cancer Hospital, Cancer Hospital of Guangxi Medical University, Eye & Ent Hospital of Fudan University, First Affiliated Hospital of Fujian Medical University, Fudan University, Jiangxi Provincial Cancer Hospital, National Cancer Centre, Singapore, People's Hospital of Guangxi, Taichung Veterans General Hospital, The First Affiliated Hospital of Xiamen University, Tongji Hospital, West China Hospital |
China, Singapore, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | From the time point the patients are included in the study, median of 3 years. | Yes | |
Secondary | Overall survival | From the time point the patients are included in the study, median of 3 years. | Yes | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | From the time point the patients are included in the study, median of 3 years. | Yes |
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