Rectal Cancer AIMS Academy Clinical Research Network Registry
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
The primary purpose of this registry is to prospectively collect data from different Mini-invasive Colo-rectal Units in Northern Italy with a standardization of the pre-operative, intra-operative and post operative setting for patients operated on for non metastatic rectal cancer with curative intent. The secondary aim is to collect in a registry the compliance to oncological treatments and the oncological outcomes for the same patients
详细描述
Study parameters
Patients with an histological diagnosis of rectal cancer will undergo pre-operative staging as follow:
- Chest-Abdominal TC scan with e.v. contrast.
- Complete colonoscopy
- Pelvic MRI with e.v. contrast with measurements of all the tumours aspects.
- Endorectal US examination
- Serum level of CEA and CA 19,9 and full nutritional status will be analysed
- Complete oncological and pathological medical history examination.
- Data from place of birth and places where patients lived will be collected.
- Sex and race Charlson Comorbidities Index adjusted for age will be calculated for each patient while Robinson Score will be calculated for aged over 70 patients.
Symptoms at presentation (Haemorrhagic framework ,alvo alteration, pain) will be collected. For Locally advance rectal cancer neo adjuvant chemoradiotherapy will be planned. Grey dose received and total dose of chemotherapy administrated together with eventual toxicity and reasons for non completing the therapy will be collected. Patients will be re-staged with pelvic MRI, endorectal US, colonoscopy. Radiological and endoscopic disease response to neo adjuvant treatment criteria will be noted.
Intraoperative analysed parameters will include :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •non metastatic rectal cancer with the indication for a curative treatment
排除标准
- 未提供
结局指标
主要结局
Disease free survival
时间窗: at 5 years from surgery
Survival rate
Over all survival
时间窗: at 5 years from surgery
Survival rate
Local recurrences
时间窗: at 5 years from surgery
Recurrences rate
Distant recurrence
时间窗: at 5 years from surgery
Recurrences rate
次要结局
- Quality of life Scale (QOLS)(at 5 years from surgery)