A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning.
研究概览
简要总结
Rationale: Computer systems that allow doctors to create a 3 dimensional (3-D) picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as cisplatin, may make tumor cells more sensitive to radiation therapy.
详细描述
PURPOSE: This clinical trial is studying magnetic resonance imaging-based radiation therapy and cisplatin in treating patients with stage I, stage II, stage III, or stage IV cervical cancer.Detailed DescriptionPRIMARY OBJECTIVES:
I. To evaluate the feasibility of using MRI based treatment planning for intracavitary brachytherapy treatment planning.
SECONDARY OBJECTIVES:
I. To evaluate the incidence of early toxicities, specifically genitourinary and gastrointestinal.
II. To evaluate the incidence of late toxicities, specifically genitourinary and gastrointestinal.
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
- •Subjects must have histologically confirmed squamous cell, adenosquamous or adenocarcinoma of the cervix
- •Subjects must have non-metastatic FIGO Stage Ia-IVa cervical cancer
- •Claustrophobic subjects must agree to be sedated during MRI procedures
- •ECOG performance status of 0-2
排除标准
- •Subjects with an inability to tolerate MR imaging
- •Subjects who have had prior surgery for treatment of disease other than exploratory laparotomy or biopsy
- •Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants
- •Women of childbearing potential who have a positive result on screening serum pregnancy test
研究组 & 干预措施
Arm I
Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.
干预措施: intracavitary balloon brachytherapy (Radiation)
Arm I
Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.
干预措施: external beam radiation therapy (Radiation)
Arm I
Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.
干预措施: intensity-modulated radiation therapy (Radiation)
Arm I
Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.
干预措施: radiation therapy treatment planning/simulation (Radiation)
Arm I
Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm I
Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning.
时间窗: Completion of study
Feasibility will be defined if no greater than 10% of patients experience one of the following events: a) patient is unable to tolerate 50% of MRI-based brachytherapy treatments and b) patient experiences any grade 4 acute ("early") non-hematologic toxicity attributed to brachytherapy. Acute toxicity occurs within 60 days of therapy.
次要结局
- Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series.(60 days post treatment)
- True Pelvis Failure(Time to local recurrence)
- Progression-free Survival(Time to recurrence)
- Pelvis Failure(Time to loco-regional recurrence)
- Overall Survival(Time to death)