A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 93
- 试验地点
- 4
- 主要终点
- Local-regional recurrence free survival (LRFS)
研究概览
简要总结
The purpose of this study is to explore whether 18F-FDG PET/CT guided reduced-dose radiotherapy would maintain survival outcomes in nasopharyngeal carcinoma (NPC) patients.
详细描述
Enrolled patients with complete metabolic response (CMR) and more than 70% partial metabolic response (PMR) according to PERCIST criteria at the 25th fraction will receive intensity modulated radiation therapy (IMRT) of reduced-dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions), for those who with ≤70% PMR will receive conventional dose (prescribed dose, 70Gy, 2.12 Gy per fractions, 33 fractions).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathology confirmed nasopharyngeal squamous cell carcinoma.
- •Stage I-IVA（8thAJCC/UICC staging system).
- •Aged 18-80 years.
- •Have measurable lesions on 18F-FDG PET/CT before treatment.
- •HGB≥90 g/L，ANC≥1.5×109 /L，PLT≥80×109 /L.
- •ALT,AST<2.5 fold of ULN；TBIL<2.0×ULN.
- •CCR≥60ml/min or Cr<1.5×ULN.
- •Signed informed consent.
- •Have follow up condition.
排除标准
- •Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ).
- •Age <18 or >80years.
- •Pregnancy or lactation.
- •History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- •Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- •With sever infection and internal disease.
- •Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate surgical treatment.
研究组 & 干预措施
Reduced dose group
The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
干预措施: Reduced dose (Radiation)
Reduced dose group
The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
干预措施: Chemotherapy (Drug)
Conventional dose group
The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
干预措施: Conventional dose (Radiation)
Conventional dose group
The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Local-regional recurrence free survival (LRFS)
时间窗: 5 years
The LRFS is evaluated and calculated from the date of initiation of treatment until the day of first locoregional relapse or until the date of the last follow-up visit.
次要结局
- Overall survival (OS)(5 years)
- Distant metastasis-free survival (DMFS)(5 years)
- Incidence of treatment related late complications(up to 5 years)
- Incidence of treatment related acute complications(up to 3 months)
- Progression free survival (PFS)(5 years)
- Overall response rate(up to 5 years)
研究者
Haihua Yang
Head of Department of Radiation Oncology
Taizhou Hospital