NCT02438839进行中（未招募）不适用
Curative Chemoradiation of Low Rectal Cancer. A Prospective Multicenter Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 5
- 主要终点
- Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment
研究概览
简要总结
The aim of the present study is to investigate whether curative chemoradiation of low rectal cancer is feasible, safe and effective in a multicenter study with results comparable to those of single center studies.
Results from previous studies indicate that a considerable fraction of patients with low rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be spared from operation.
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
- •Histopathologically verified adenocarcinoma of the rectum
- •Planned abdominoperineal resection (APR) or ultralow resection
- •Primary, resectable T1-T3, N0 tumor. N1 nodal disease is acceptable, if the positive lymph nodes are localized to the mesorectum at the level of the tumor.
- •Distance from anal verge to lower edge of tumor ≤ 6 cm measured by rigid rectoscope
- •Performance status 0-2
- •Patient acceptance to collection of biopsies and blood samples for translational research
- •Age ≥ 18 years
- •Normal function of bone marrow as evaluated by
- •neutrophils ≥ 1.5 x 10^9/l
- •thrombocytes ≥ 100
- •Normal function of liver
- •alanine aminotransferase (ALAT) < 2.5 x upper limit of normal
- •bilirubin < 2.5 x upper limit of normal
- •Kidney function
- •- Serum creatinine < 1.5 x upper limit of normal or measured glomerular filtration rate (GFR) > 30 ml/min
- •Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
- •Written and orally informed consent
排除标准
- •Previous surgical treatment of the present cancer, including transanal excision of tumor.
- •Other malignant disease within the past five years except basocellular skin cancer and carcinoma in situ cervicis uteri
- •Distant metastases verified by imaging or biopsy
- •Previous radiation treatment of the pelvis
- •Pregnant or breastfeeding women
结局指标
主要结局
Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment
时间窗: 2 years after end of treatment
次要结局
- Cumulative incidence of local recurrence after surgery(Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years)
- Rate of distant metastases(Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years)
- Response and tumor control on MRI scans compared to clinical observations, including rectoscopic examination(6 and potentially 12 weeks after end of treatment)
研究者
研究点 (5)
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