Feasibility of PET-scan Carried Out at Day 1 of Brachytherapy for Patients With Locally Advanced Cervical Cancer Treated Initially by Concomitant Radio-chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) in terms of realized exams
研究概览
简要总结
Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan
详细描述
The study will proceed as follow:
- Initial check-up before the brachytherapy, including a clinical exam, collect of disease history and other informations that can be required for a good execution of the trial, and a usual patient care (chemotherapy with concomitant radiotherapy, biopsy, RMI, PET-scan and paraaortic lymphadenectomy).
- additional PET-scan exam at day 1 of the brachytherapy (with collect of informations on toxicity, clinical morphology data and biomorphological data of RMI and PET-scan, and dosimetric study of the brachytherapy)
- 4 months after the brachytherapy, additional PET-scan monitoring metabolic volumes and standardized metabolic fixation parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient suffering from a cervical cancer:
- •squamous-cell carcinoma or adenocarcinoma histologically proven
- •classified from FIGO 2009 IB2 to IVA stage
- •Age ≥ 18 years old
- •Examination by PET-scan and pelvic RMI realized at diagnosis
- •Examination by negative PET-scan remotely closed and at lymph node level
- •Surgical lymphadenectomy negative at paraaortic level
- •Treatment by external radiotherapy (doses between 45 Gy and 50.4 Gy in 1.8 Gy/fractions) and concomitant chemotherapy (at least 4 cures per weeks using platinum salt) done
- •Scheduled curative treatment by brachytherapy driven by RMI
- •Affiliation to the National Social Security System
- •With informed and signed consent before any procedure specific to the study
排除标准
- •Performance status of WHO score > 2
- •Other histology than squamous cell carcinoma or adenocarcinoma
- •Metastatic patient or paraaortic node positive
- •Adjuvant radiochemotherapy after the first surgery
- •Dementia or psychiatric history
- •Kidney failure
- •Chronic inflammatory bowel disease
- •Pelvic and/or vesicoureteral surgery history
- •Pelvic irradiation history
- •Other active neoplasia or < 5 years old, except for basocellular carcinoma that can be locally treated
- •Contraindication to one of the following procedure : RMI, PET-scan, general anesthesia
- •Radiosensitive disease (Fragile X syndrome, Huntington's chorea, Xeroderma Pigmentosum, connective tissue disease) or signs of radiosensitivity.
- •Treatment with palliative intent
- •Pregnant or breastfeeding women
- •Patient Under guardianship or tutorship
研究组 & 干预措施
Study Procedure
Brachytherapy. PET-scan.
干预措施: Brachytherapy (Procedure)
Study Procedure
Brachytherapy. PET-scan.
干预措施: PET-scan (Other)
结局指标
主要结局
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) in terms of realized exams
时间窗: 4 months
Concerning this outcome, the success in terms of feasibility will be the possibility of realizing the TEP-Curie exam
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the contouring possibility
时间窗: 4 months
Using the possibility of defining the contouring for at least one of the 3 alternative treatment plans
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the possibility to define HR-CTV target volume (High-Risk Clinical Target Volume)
时间窗: 4 months
Concerning this outcome, the success in terms of feasibility will be the possibility of defining a HR-CTV target volume for at least one of the 3 proposed approaches using the PET
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the dicom medical image transfer
时间窗: 4 months
Concerning this outcome, the success in terms of feasibility will be the possibility of transfering image in a Dicom format
次要结局
- Impact of the "TEP-Curie" (Brachytherapy driven by PET-scan) on target volume definition(4 months)
- Assessment of the dose received by the neighboring target organs(4 months)
- Time needed to design the different alternative treatment plans(4 months)
- Toxicity linked to the standard treatment driven by RMI only(4 months)
- Assessment of the HR-CTV coverage(4 months)