A Phase I/II Study for Image Guided Stereotactic Body Radiation Therapy Boost for Definitive Treatment of Locally Advanced Cervical Cancer (LACC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Dosimetric Feasibility of SBRT boost
研究概览
简要总结
This study will evaluate the role of SBRT with the aim to reproduce high dose rate brachytherapy (HDR BT) dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.
详细描述
This is a phase I/II feasibility study of hypofractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to LACC with the aim to reproduce HDR BT dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.
Eligible patients who consent to participate in the current study will receive 4 image-guided SBRT sessions to a prescription of 7 Gray per fraction to the LACC (HR-CTV) following whole pelvis external beam radiotherapy.
SBRT will start within one week after whole pelvis external beam radiotherapy. The study will enroll a total of 30 patients. After treatment, patients will be followed-up at 1 month, at 3 months (+/- 1 week), at 6 months (+/- 4 weeks), and then every 6 months (+/- 6 weeks) until the end of the 3rd year, then annually until the 5th year.
The equivalence of outcome and toxicity will be measured by comparing the data obtained in the study to literature data regarding the standard modality of brachytherapy. Patients' oncological outcomes, toxicity and quality of life data will be reported.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cancer of the uterine cervix suitable for curative treatment with definitive radio-chemotherapy
- •Biopsy proven showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
- •Pelvic MRI.
- •MRI and Positron emission tomography (PET-CT) of the retroperitoneal space and abdomen at diagnosis is performed.
- •Stage IIB to IVA according to International Federation of Gynecological and Obstetrics (FIGO) and TNM guidelines.
- •Planning MRI with the applicator in place for the SBRT boost.
- •Para-aortic metastatic nodes below L1-L2 are allowed.
- •Study specific signed patient informed consent.
排除标准
- •Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin.
- •Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix.
- •Metastatic disease above and beyond the retroperitoneal paraaortic L1-L2 interspace.
- •Previous pelvic or abdominal radiotherapy.
- •Previous total or partial hysterectomy.
- •Contra-indications to MRI.
- •Severe psychiatric condition.
- •Severe, active co-morbidity.
结局指标
主要结局
Dosimetric Feasibility of SBRT boost
时间窗: through study completion, an average of 3 year
Fulfillment of protocol dosimetrical endpoints and constraints
reproducibility of SBRT boost
时间窗: Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold
Inter/intra fractional target motion
时间窗: during the 15 minutes of treatment delivery time
3D deviations recorded in CBCT images and electromagnetic recording
Adverse Events
时间窗: through study completion, an average of 3 years
Treatment related side effects based on CTCAE V5.0
Local control
时间窗: through study completion, an average of 3 years
Free from loco-regional relapse
次要结局
- Distant Relapse(through study completion, an average of 3 years)
- Quality of life metrics(through study completion, an average of 3 years)
研究者
Inês Antunes
Principal Investigator
Fundacao Champalimaud