Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and pCR After Neoadjuvant Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
研究概览
简要总结
Pathologic complete response (pCR) after multimodal treatment for locally advanced rectal cancer (LARC) patients is considered as the gold-standard of treatment success as it is associated to privileged oncologic outcome. Nevertheless, data from multicenter high-volume cohorts with long term follow-up are scarce.
This is a multicenter observational study using prospectively collected data from the Spanish Rectal Cancer Project database.
The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
Secondary objective is to analyze demographic, clinical, operative and treatment variables in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
The results are reported in accordance with the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) Statement for observational studies.
All calculations are performed using Stata 13.1 (StataCorp, Texas, USA).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathological confirmation of rectal cancer preoperatively, in any of its histological variants.
- •Tumor located less than 12 cm from the anal margin.
- •Radiological stage II or III (cT3-4 N0 and/or any T with positive cN).
- •Neoadjuvant treatment with radio-chemotherapy.
- •Radical surgery performed on a scheduled basis and with curative intent.
- •Definitive pathology study with complete tumor regression.
排除标准
- •Patients operated on with palliative intent.
- •Patients diagnosed with a hereditary colorectal cancer syndrome.
- •Patients who presented synchronous metastases at the time of diagnosis, or concurrent malignancy of another origin.
- •Patients who underwent emergency surgery.
结局指标
主要结局
The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
时间窗: May 2022-June 2022
Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
次要结局
- To analyze clinical data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.(May 2022-June 2022)
- To analyze demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.(May 2022-June 2022)
- To analyze operative and treatment data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.(May 2022-June 2022)
- To analyze further demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.(May 2022-June 2022)
研究者
Carlos Cerdán Santacruz
Colorectal Surgery Department at Hospital Universitario de la Princesa, Madrid. Spain. ORCID: 0000-0002-6507-900X
Hospital San Carlos, Madrid