NCT06462378招募中2 期
Proton Therapy in Locally Advanced Cervical Cancer in Combination With Concomitant Chemotherapy and Brachytherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Acute Bone marrow toxicity
研究概览
简要总结
The purpose of this protocol is to determine toxicity and efficacy of proton therapy in combination with standard concomitant platinum-based chemotherapy and standard image-guided adaptive brachytherapy (IGABT) in patients with locally advanced cervical cancer (LACC). The over-all aim is to maintain a high disease control and at the same time reduce acute morbidity as well as late side effects after treatment.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Cancer of the uterine cervix considered suitable for curative treatment with definitive radio- (chemo) therapy including IGABT
- •Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
- •Staging according to Intenational federation of Gynecology and Obstetrics (FIGO) and TNM guidelines
- •T1-3N1M0 (FIGO stage IIIC1 (with ≥3 pelvic lymph node metastases) and IIIC2)
- •Para-aortic metastatic nodes below L1-L2 are allowed (FIGO stage IVB)
- •Magnetic Resonance Imaging (MRI) and Positron Emission Tomogaraphy-computerized Tomograpy (PET-CT) of the retroperitoneal space and abdomen at diagnosis
- •Patient written, informed consent
- •Age≥18 years
- •Patients must be able to understand a Danish or Swedish
排除标准
- •Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
- •Metastatic disease beyond para-aortic region (L1-L2 interspace)
- •Previous pelvic or abdominal radiotherapy
- •Combination of preoperative radiotherapy with surgery
- •Patients receiving neoadjuvant chemotherapy
- •Contra indications to MRI
- •Contra indications to IGABT
- •Contra indications to protontherapy
- •Small cell histology (neuroendocrine tumors)
- •Active infection or severe medical condition endangering treatment delivery
- •Pregnant, lactating or childbearing potential without adequate contraception
- •Human Immune Deficiency Virus (HIV)
- •Patients with no possibility of follow up
结局指标
主要结局
Acute Bone marrow toxicity
时间窗: Worst recorded baseline to 3 months after RT
Grade 2+ Bone marrow toxicity
次要结局
- Toxicity(baseline to 5 years after RT)
- Dosimetrics outcomes(3 month)
- cisplatin(3 month)
- Oncological outcomes(5-year)
- Late bone marrow toxicity(>3 month to 5 years after RT)
- Patient Reported outcomes(baseline to 5 years after treatment)
研究者
研究点 (1)
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