NCT01257035终止不适用
The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Response to chemoradiotherapy measured by TRG
研究概览
简要总结
The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of response to neoadjuvant chemoradiation of locally advanced rectum cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopatologically verified adenocarcinoma in the rectum
- •T4 tumor eller T3 tumor < 10 cm from the anus and < 5 mm from the mesorectal fascie measured by MR scan. At the distal part of the rectum the distance to the mesorectal fascie is < 5 mm and therefore all T3 tumors are included in this area
- •Suitable for preoperative radiation and chemotherapy
- •No distant metastases
- •Age >18 years
- •Hematology ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
- •Biochemistry Bilirubin ≤ 3 x UNL. ALAT ≤ 5 x UNL
- •Creatinine ≤ UNL
- •Contraception for fertile women
- •Written and orally informed consent
排除标准
- •Other malignant disease within 5 years, excl. non-melanotic skin cancer
- •Previous radiation treatment of the pelvis
- •Pregnant or breastfeeding women
- •Surgery within 6 weeks prior to enrollment
- •Serious concurrent medical disease
- •Enrollment in study "A prospective observational study of patients with rectum cancer after concomitant radiation and chemotherapy", where the patients are potientially not operated.
结局指标
主要结局
Response to chemoradiotherapy measured by TRG
时间窗: 8 weeks after chemoradiation treatment
次要结局
- Recurrence free survival(From date of inclusion till date of verified recurrence)
- Survival(From date of inclusion till date of death by any cause)
研究者
研究点 (1)
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