Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Postoperative Cervical Cancer (AMICA-CC) : a Prospective, Multicenter, Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Acute toxicities
研究概览
简要总结
To investigate the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy in the treatment of postoperative cervical cancer
详细描述
This multicenter, phase II trial was conducted to assess the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy in patients with cervical cancer after hysterectomy. The primary endpoint was the incidence of acute grade 3 or higher gastrointestinal (GI), genitourinary (GU), and hematologic toxicities during radiotherapy (RT) or within three months after RT completion, based on the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. The secondary endpoints included late toxicities, scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) / Cervical Cancer Module (CX24), disease-free survival (DFS), and overall survival (OS).
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status 0 or 1;
- •Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- •Status post radical hysterectomy with pelvic lymph node dissection with or without para-aortic lymph node dissection, and postoperative radiotherapy initiated within 3 months;
- •For squamous cell carcinoma: meeting Sedlis criteria; for adenocarcinoma and adenosquamous carcinoma: meeting the "four-factor model";
- •Bone marrow function: white blood cell (WBC) count ≥3.0×10⁹/L, neutrophil count (NEUT) ≥1.5×10⁹/L, platelet count (PLT) ≥80×10⁹/L, hemoglobin (Hb) ≥90 g/L; renal function: normal or serum creatinine (SCr) ≤1.5×upper limit of normal (ULN) or creatinine clearance ≥50 ml/min; hepatic function: total bilirubin (TBIL) ≤1.5×ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5×ULN;
- •Voluntarily signed the informed consent form prior to study enrollment.
排除标准
- •History of active malignant tumor within 3 years prior to initial treatment（except for the cervical cancer）and any locally curable tumors treated with radical therapy;
- •Any high-risk factor confirmed by postoperative pathology: positive lymph node metastasis, positive parametrial invasion, or positive resection margin;
- •History of neoadjuvant therapy prior to enrollment;
- •Local recurrence or distant metastasis prior to enrollment;
- •Postoperative intestinal obstruction or intestinal adhesion;
- •Severe cardiac, cerebral, hepatic, or renal disorders;
- •Long-term immunocompromised state;
- •Pregnant or lactating females;
- •Premature discontinuation of treatment for any reason;
- •Poor compliance, unwillingness to participate, or inability to cooperate with follow-up;
- •Any other conditions deemed unsuitable for this trial by the investigator.
研究组 & 干预措施
Postoperative Radiotherapy
Patients undergo moderately hypofractionated IMRT after radical hysterectomy
干预措施: Postoperative Radiotherapy (Radiation)
结局指标
主要结局
Acute toxicities
时间窗: 3 months
the incidence of acute grade 3 or higher gastrointestinal (GI), genitourinary (GU), and hematologic toxicities during radiotherapy (RT) or within three months after RT completion, based on the CTCAE version 6.0
次要结局
- Late toxicities(1 year)
- Disease-Free Survival（DFS）(2-years)
- Overall Survival (OS)(2-years)
- Patient-reported quality of life(2-years)
- Disease-Free Survival (DFS)(2-years)
研究者
Manni Huang
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences