NCT01999660终止不适用
Prospective National Post-marketing Surveillance for the Investigation of the Efficacy and Safety of SpaceOAR™ to Maintain Space Between the Rectum and Prostate During Radiation Therapy
CS Diagnostics GmbH1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2013年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- the rectal complication rate (late toxicity)
研究概览
简要总结
A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation therapy in prostate cancer patients
详细描述
The degradable SpaceOAR™ hydrogel establishes for the time of radiotherapy a distance between the prostate and the rectum
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient is suffering from pathologically confirmed T1-T2, N0, M0 prostate adenocarcinoma.
- •Patient is intended to receive radiation therapy (3D-computerized radiotherapy, intensity-modulated radiotherapy, and/or brachytherapy) and this will be the first prostate or pelvic radiation therapy.
- •Patient is intended to receive SpaceOAR™ Gel therapy.
- •The patient is official patient of the clinical investigator in the study centre.
- •Patient agrees to fully participate in the clinical trial and give informed consent in writing.
排除标准
- •Anatomic abnormality, physical or pathological condition precluding the implantation.
- •Failure in the wall of the perineum room (with the risk that the hydrogel escapes).
- •History of prostate surgery or local prostate cancer therapy.
- •Rectal injury before implantation of SpaceOAR™ Gel or history of or active inflammatory rectal disease such as Crohn's disease or ulcerative colitis.
- •History of or current perirectal or anal disease or surgery such as prolapsed or bleeding haemorrhoids or fistula.
- •Compromised immune system (e.g., HIV/acquired immunodeficiency syndrome, auto¬immune disease or immunosuppressive therapy).
- •Platelet count, partial thromboplastin time, or white blood cell count out of normal laboratory range.
- •Contraindication for safe MRI and CT scans.
- •Patient is not able to fully participate in this study including the follow-up (e.g. for mental or geographical reasons, or patient is intravenous drug user or has strong potential for non-compliance to medical regimes).
- •Patient is mentally unable to understand the nature, aims, or possible consequences of the clinical investigation.
- •Patient has restricted legal capacity.
- •Patient did participate in another clinical investigation during the last 3 months.
- •Patient has revoked the consent.
结局指标
主要结局
the rectal complication rate (late toxicity)
时间窗: 6 months and yearly for 5 years thereafter
the rectal complication rate following the common toxicity criteria (CTC) v. 2.0
次要结局
- Quality of Life(6 months and for 5 years yearly thereafter)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy TrialBone MetastasesLower Extremity FracturePathological FractureImpending FractureNCT04109937Sunnybrook Health Sciences Centre
Unknown
3 期
Efficacy of Intensity Modulated Radiation Therapy After Surgery in Early Stage of Esophageal Carcinoma;Esophageal NeoplasmEsophageal Cancer TNM Staging Primary Tumor (T) T2Esophageal Cancer TNM Staging Primary Tumor (T) T3Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0Esophageal Cancer TNM Staging Distal Metastasis (M) M0NCT01745107Chinese Academy of Medical Sciences240
终止
不适用
Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate CancerProstate CancerNCT05224869Icahn School of Medicine at Mount Sinai10
已完成
2 期
A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast CancerBreast Cancer StageBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage IIIBreast Cancer Stage IVBreast CancerNCT05190770Memorial Sloan Kettering Cancer Center18
Unknown
2 期
Concurrent Immunotherapy With Postoperative Radiotherapy in Intermediate/High Risk HNSCC Patients Unfit for Cisplatin: The IMPORT Study (IMPORT)Head and Neck Squamous Cell CarcinomaNCT04523883Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University316