CROSSROAD: A Prospective Multicenter Observational Study on the Efficacy of Treatment Regimen Switch With Re-induction Chemotherapy Versus Direct Radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Inadequate Response (SD/PD) After Induction Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 223
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This study aims to compare the efficacy of two treatment strategies-re-induction chemotherapy followed by radiotherapy versus direct radiotherapy-in patients with locally advanced nasopharyngeal carcinoma (LANPC) who did not achieve a sufficient response (stable disease or disease progression) after two cycles of induction chemotherapy. The study will enroll patients who have completed two cycles of induction chemotherapy and have not achieved a partial or complete response. Participants will receive one of the two treatment options to evaluate their three-year progression-free survival (PFS) and other clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age: 18 to 70 years old.
- •Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II/III).
- •Initial treatment with no distant metastasis: Locally advanced nasopharyngeal carcinoma (according to the AJCC/UICC 9th edition staging, stage II-III, i.e., T3-4N0-3M0 or T1-2N2-3M0).
- •Completion of two cycles of standard induction chemotherapy (such as TPF, GP, TP, etc.).
- •Post-induction chemotherapy evaluation: Disease stability (SD) or disease progression (PD) after two cycles of induction chemotherapy, as assessed by RECIST 1.1 criteria, based on enhanced MRI of the nasopharynx.
- •ECOG Performance Status (PS): 0-
- •Bone marrow, liver, and kidney function: Sufficient to tolerate concurrent chemoradiotherapy (specific criteria to be referenced).
- •Informed consent: Voluntary participation in the study and signing of written informed consent.
排除标准
- •History of head and neck tumor radiotherapy or any other malignant cancer history (except for cured non-melanoma skin cancer).
- •Partial response (PR) or complete response (CR) after induction chemotherapy.
- •Severe uncontrolled comorbidities, such as unstable angina, congestive heart failure, severe chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes mellitus.
- •Active infection or severe immunodeficiency diseases.
- •Pregnant or breastfeeding women.
- •Any mental or social disorders that may interfere with study evaluation or compliance.
- •Other conditions deemed by the investigator to be unsuitable for participation in the study.
研究组 & 干预措施
Re-induction Chemotherapy Group
This group consists of patients with locally advanced nasopharyngeal carcinoma (LANPC) who did not achieve a sufficient response (stable disease or disease progression) after two cycles of induction chemotherapy. These patients will receive re-induction chemotherapy followed by radiotherapy as part of their treatment regimen.
Direct Radiotherapy Group
This group consists of patients with locally advanced nasopharyngeal carcinoma (LANPC) who did not achieve a sufficient response (stable disease or disease progression) after two cycles of induction chemotherapy. These patients will receive direct radiotherapy without re-induction chemotherapy.
结局指标
主要结局
Progression-Free Survival
时间窗: Baseline, 1 year, 2 years, 3 years
The primary endpoint of this study is to compare the 3-year progression-free survival (PFS) rate between the two treatment groups. Disease progression will be assessed using RECIST 1.1 criteria, with imaging exams (such as MRI) used to monitor tumor size and progression.
次要结局
- Local Regional Recurrence-Free Survival(Baseline, 1 year, 2 years, 3 years)
- Overall Survival(Baseline, 1 year, 2 years, 3 years)
- Distant Metastasis-Free Survival(Baseline, 1 year, 2 years, 3 years)
- Complete Response Rate after Radiotherapy(3 months post-treatment)
- 3-4 Grade Acute Toxicity Incidence(through study completion, an average of 4-6 months)
研究者
Qiaojuan Guo
Director, Department of Head and Neck Radiation Oncology, Clinical Professor
Fujian Cancer Hospital