Spots Global Cancer Trial Database for Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
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Trial Identification
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 ID: NCT02944708
Conditions
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University Cancer Hospital, Beijing, Beijing, 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, China
Shanghai Proton and Heavy Ion Center, Shanghai, Shanghai, China
Eye & ENT Hospital of Fudan University, Shanghai, Shanghai, China
West China Hospital, Chengdu, Sichuan, China
National Cancer Centre, Singapore, Singapore, , Singapore
Taichung Veterans General Hospital, Taichung, , Taiwan
Contact Details
Name: Jiade J Lu, MD
Affiliation: Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
Role: PRINCIPAL_INVESTIGATOR
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