Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- Drug: Conventional chemotherapyDrug: Maintenance chemotherapy 1Drug: Maintenance chemotherapy 2
- Registration Number
- NCT02944708
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 384
- Age β₯ 18 and β€ 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 β₯ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maintenance chemotherapy 1 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. Maintenance chemotherapy 1 Conventional chemotherapy 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. Maintenance chemotherapy 2 Conventional 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. Conventional chemotherapy 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. Maintenance chemotherapy 2 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.
- Primary Outcome Measures
Name Time Method Progression-free survival From the time point the patients are included in the study, median of 3 years.
- Secondary Outcome Measures
Name Time Method Overall survival From the time point the patients are included in the study, median of 3 years. 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.
Trial Locations
- Locations (14)
Jiangxi Provincial Cancer Hospital
π¨π³Nanchang, Jiangxi, China
Eye & ENT Hospital of Fudan University
π¨π³Shanghai, Shanghai, China
National Cancer Centre, Singapore
πΈπ¬Singapore, Singapore
Peking University Cancer Hospital
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of Fujian Medical University
π¨π³Fuzhou, Fujian, China
The People's Hospital of Guangxi Zhuang Autonomous Region
π¨π³Nanning, Guangxi, China
Tongji Hospital, Tongji Medical College of HUST
π¨π³Wuhan, Hubei, China
Jiangxi Province Tumor Hospital
π¨π³Nanchang, Jiangxi, China
West China Hospital
π¨π³Chengdu, Sichuan, China
Fudan University Shanghai Cancer center
π¨π³Shanghai, Shanghai, China
Taichung Veterans General Hospital
π¨π³Taichung, Taiwan
The First Affiliated Hospital of Xiamen University
π¨π³Xiamen, Fujian, China
Cancer Hospital of Guangxi Medical University
π¨π³Nanning, Guangxi, China
Shanghai Proton and Heavy Ion Center
π¨π³Shanghai, Shanghai, China