NCT05749887招募中不适用
Salvage Surgery for Patients With Residual Disease After Concurrent Chemoradiation Therapy for Locally Advanced Cervical Cancer: A Prospective, Single-arm Clinical Study.
Chongqing University Cancer Hospital1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2023年8月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
This is a single-center single-arm study. The main purpose of this study is to study the efficacy of surgical treatment for patients with locally advanced cervical cancer (FIGO IB3, IIA2-IVA) who still have residual tumor after concurrent radiotherapy and chemotherapy.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage Ib3 and IIA2-IVA (FIGO2018) cervical cancer with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma.
- •Complete standard CCRT(Pelvic EBRT+ concurrent platinum-containing chemotherapy+ brachytherapy).
- •After 4-12 weeks of treatment, the cervical biopsy pathology confirmed residual cancer, or the cervical biopsy was negative, but PET /CT showed that SUVmax of the residual lesions in the cervical and/or pelvic lymph nodes were ≥ 2.5, two or more gynaecological oncologists with Grade IV operation qualification and the title of deputy director or above have gynecological examination, and the multidisciplinary team(MDT) evaluation recommended surgical treatment.
- •ECOG score:0 ~
- •The expected survival time>6 months;
- •There is no absolute contraindication of surgery and the patients with good compliance.
排除标准
- •The radiotherapy and chemotherapy are not completed or the radiotherapy dose is not reached.
- •PET /CT and/or pathological indicates that there is a distant metastasis including para-aortic lymph nodes.
- •Other malignancies were diagnosed within five years or needed treatments.
- •History of important organ transplantation.
- •History of immune disease who need to take immunosuppressive drugs.
- •History of serious mental illness and brain functional disorder.
- •Drug abuse or drug use history.
- •Participants in other clinical trials at the same time.
- •Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements.
- •Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians.
- •Patients who cannot understand the research regimen and refuse to sign the informed consent form.
- •Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
结局指标
主要结局
OS
时间窗: 5 years
5 years overall survival
次要结局
- PFS(2 years)
研究者
Dongling Zou
Director of Gynecologic Oncology Department
Chongqing University Cancer Hospital
研究点 (1)
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