A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 384
- 试验地点
- 14
- 主要终点
- Progression-free survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Conventional chemotherapy (Drug)
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.
干预措施: Conventional chemotherapy (Drug)
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.
干预措施: Maintenance chemotherapy 1 (Drug)
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.
干预措施: Conventional chemotherapy (Drug)
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.
干预措施: Maintenance chemotherapy 2 (Drug)
结局指标
主要结局
Progression-free survival
时间窗: From the time point the patients are included in the study, median of 3 years.
次要结局
- 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.)
研究者
Lin Kong
Consultant doctor, chair of head and neck cancer
Shanghai Proton and Heavy Ion Center