Predictive-Model Based Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma: A Phase 2 Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This is a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized carbon-ion radiotherapy (CIRT). For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups.
详细描述
This is a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized CIRT with a dose of 63 gray equivalent (GyE) in 21 fractions (fx). This regimen was obtained from our previous phase 1 (dose escalation) study. For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups. The secondary endpoints include 2-year overall survival (OS), local progression-free survival, regional progression-free survival, distant metastasis-free survival, toxicities and quality of life.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 17-70 years.
- •Pathologically diagnosed as WHO type 2/3 nasopharyngeal carcinoma.
- •Failed previous definitive radiotherapy at least 6 months ago.
- •Only had 1 previous course of radiotherapy.
- •Eastern Cooperative Oncology Group score: 0-
- •Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil > 2000/mm^3; 2) platelet > 100,000/mm^3; 3) total bilirubin < 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase < 1.5 upper limit of normal; 5) SCr < 1.5mg/dl; creatinine clearance rate > 60ml/min.
- •Willing to accept adequate contraception for women with childbearing potential.
- •Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial.
排除标准
- •Presence of distant metastasis.
- •Without measurable lesion.
- •Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
- •Accompanied with severe major organ dysfunction.
- •Presence of mental disease that may influence the understanding of informed consent.
结局指标
主要结局
Progression-free survival
时间窗: From randomization to death or disease progression, a median of 2 years
次要结局
- Regional progression-free survival(From randomization to regional failure, a median of 2 years)
- Distant metastasis-free survival(From randomization to distant metastasis, a median of 2 years)
- Quality of life by questionnaires evaluated using EORTC-H&N35 questionnaire.(Throughout the study, an average of 2 years)
- Incidence of radiation-induced late toxicity evaluated by CTCAE 5.0(Three months after initiation of radiation therapy)
- Quality of life by questionnaires evaluated using EORTC-Q30 questionnaire.(Throughout the study, an average of 2 years)
- Overall survival(From randomization to death, a median of 2 years)
- Local progression-free survival(From randomization to local failure, a median of 2 years)
- Incidence of radiation-induced acute toxicity evaluated by CTCAE 5.0(Within 3 months after initiation of radiation therapy)
研究者
Jiade J. Lu
Prof. Jiade J. Lu
Shanghai Proton and Heavy Ion Center