NCT05634681招募中不适用
Plan-of-the-day Radiotherapy for Patients With Locally Advanced Cervical Cancer - a Prospective Randomized Controlled Trial (the POD-protocol)
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2022年11月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- To investigate whether implementation of the plan of the day concept results in less gastro-intestinal toxicity.
研究概览
简要总结
The study objectives are to improve the treatment of LACC patients and to increase knowledge of the potential benefit of the plan-of-the-day concept on side effects during and after radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Histologically confirmed cervical cancer eligible for definitve radiochemotherapy
- •FIGO stage IB1-IVa
- •Over 18 years
- •Speaks and understands Norwegian or English.
- •Histology: Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma
- •Ability to understand and fill in patient questionnaires, and willing to sign a written informed consent
- •Large movers (LM), fundus movement ≥2,5 cm.
排除标准
- •Evidence of distant metastasis. Suspicious paraaortic lymphnodes below the renal vessels is allowed if they are covered by the radiation field
- •Patients with previous surgery for their cervical cancer
- •Uncontrolled intercurrent somatic illness.
- •Psychiatric illness /social situations limiting study compliance
- •Prior radiotherapy to the pelvis
- •Patients who are pregnant or breastfeeding is excluded due to risk of teratogenic and abortifacient effects of radiotherapy and cisplatin, and the potential risk of adverse effect of nursing infants
- •Patients under current treatment for other invasive s except non-melanoma skin cancers
- •Nephrostomy
- •Patients with inflammatory bowel disease
研究组 & 干预措施
Control arm
Active Comparator
干预措施: Standard plan (Radiation)
Intervention arm
Experimental
干预措施: Plan of the day (Radiation)
结局指标
主要结局
To investigate whether implementation of the plan of the day concept results in less gastro-intestinal toxicity.
时间窗: 5 weeks
To compare the change in patient reported acute diarrhea from baseline to week 4 from start of the treatment and to the end of external radiotherapy. Item 17 in EORTC QLQ-C30
次要结局
未报告次要终点
研究者
Kjersti Bruheim
MD PhD
Oslo University Hospital
研究点 (1)
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