Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Cervical Cancer
2026年8月3日 更新者：Manni Huang
Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Postoperative Cervical Cancer (AMICA-CC) : a Prospective, Multicenter, Phase II Trial
To investigate the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy in the treatment of postoperative cervical cancer
研究概览
详细说明
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).
研究类型
介入性
注册 (估计的)
154
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：MAN NI HUANG, MD
- 电话号码：8610-87788495
- 邮箱：huangmanni@csco.ac.cn
学习地点
-
-
Beijing Municipality
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Beijing、Beijing Municipality、中国、100021
- 招聘中
- Cancer Hospital, Chinese Academy of Medical Sciences
-
接触：
- MAN NI HUANG, MD
- 电话号码：8610-87788495
- 邮箱：huangmanni@csco.ac.cn
-
首席研究员：
- MAN NI HUANG, MD
-
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Hebei
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Langfang、Hebei、中国、065001
- 招聘中
- Lang Fang Campus of Cancer Hospital, Chinese Academy of Medical Sciences
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接触：
- JU SHENG AN, MD
- 电话号码：0316-5918495
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首席研究员：
- JU SHENG AN, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Postoperative Radiotherapy
Patients undergo moderately hypofractionated IMRT after radical hysterectomy
|
Postoperative moderately hypofractionated IMRT (2.5Gy per fraction, 17 fractions, once a day)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acute toxicities
大体时间：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
|
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Late toxicities
大体时间：1 year
|
evaluation of late toxicities during three months to one year after RT completion according to CTCAE version 6.0
|
1 year
|
|
Overall Survival (OS)
大体时间：2-years
|
the time from the start of study treatment to death from any cause.
|
2-years
|
|
Disease-Free Survival (DFS)
大体时间：2-years
|
the time from initiation of study treatment to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause.
|
2-years
|
|
Patient-reported quality of life
大体时间：2-years
|
scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) / Cervical Cancer Module (EORTC QLQ-CX24).The scale ranges from 0 to 100, where higher scores represent better quality of life.
|
2-years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：MAN NI HUANG, MD、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月10日
初级完成 (估计的)
2030年12月30日
研究完成 (估计的)
2030年12月30日
研究注册日期
首次提交
2026年6月29日
首先提交符合 QC 标准的
2026年6月29日
首次发布 (实际的)
2026年7月6日
研究记录更新
最后更新发布 (实际的)
2026年8月5日
上次提交的符合 QC 标准的更新
2026年8月3日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.