Phase I/II Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Salvaging Treatment of Locally Recurrent Nasopharyngeal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) along with concurrent chemotherapy in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens along with concurrent chemotherapy (40 mg/m^2, weekly) to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 4 months after the completion of concurrent chemoradiotherapy. Once the MTD for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.
详细描述
The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) along with concurrent chemotherapy in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD in the setting of concurrent chemoradiotherapy. Participants will be treated with CIRT with escalating dose starting from 52.5GyE (2.5GyE/daily fraction) to potentially 62.5GyE (2.5GyE/daily fraction) along with concurrent chemotherapy (40 mg/m^2, weekly) to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 4 months after the completion of concurrent chemoradiotherapy. Time-to-event continual reassessment method (TITE-CRM) is used for the phase I dose escalating part of the trial and approximately 25 patients will be accrued. Once the MTD in the setting of concurrent chemoradiotherapy for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial. The Phase II part of the trial will be a single phase single arm study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-Pathologically confirmed NPC
- •Completed a definitive course of intensity-modulated photon radiation therapy (IMXT) to a total dose of ≥ 66 Gy
- •Recurrence diagnosed more than 12 months after the initial course of IMXT
- •Age ≥ 18 and < 70 years of age
- •Karnofsky Performance Score ≥70
- •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
- •Local recurrence of NPC diagnosed within 12 months from the completion of previous course of radiation therapy
- •Presence of distant metastasis
- •Technology used other than IMXT (including brachytherapy following IMXT) for the treatment of initial diagnosis of NPC
- •Pregnant or lactating women
- •Patients who have not yet recovered from acute toxicities of prior therapies
- •A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within the past 5 years
- •Refusal of the patient to participate into the study
研究组 & 干预措施
CIRT with concurrent chemo arm
Treated with carcon ion radiotherapy along with concurrent chemotherapy (Cisplatin 40mg/m^2, weekly).
干预措施: Carbon ion radiotherapy (CIRT) (Radiation)
CIRT with concurrent chemo arm
Treated with carcon ion radiotherapy along with concurrent chemotherapy (Cisplatin 40mg/m^2, weekly).
干预措施: Cisplatin (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Time interval from the start to 4 months after the completion of concurrent chemoradiotherapy
次要结局
- Overall survival of all patients(From the diagnosis of local recurrence of NPC, a median of 2 years)
- Progression-free survival of all patients(Time Frame: From the completion of CIRT, a median of 2 years)
研究者
Jiade J. Lu
MD
Shanghai Proton and Heavy Ion Center