"Watch and Wait" in Patients With Complete Clinical Response (cCR) After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 7
- 主要终点
- Rate of regrowth
研究概览
简要总结
Among patients treated for locally advanced rectal cancer with neo-adjuvant radio-chemotherapy, about 15% will have complete clinical response in terms of no visible tumor or ulcerations on the site of the primary tumor, or whitening of the rectal wall or telangiectasia. In this Norwegian national multicenter observational study, patients with complete clinical response (cCR) after neo-adjuvant treatment for rectal cancer as defined by national guidelines, will be invited to a Watch&Wait program with a specially designed follow-up in order to see if the tumor has disappeared permanently, or if there is regrowth of the tumor. Primary endpoint is the true regrowth rate in an unselected national cohort of patients.
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
- •Histologically verified adenocarcinoma of the rectum within 15 cm from the anal verge measured by rigid proctoscopy
- •Patients who have completed neoadjuvant treatment according to national guidelines for rectal cancer, i.e., radiotherapy or chemo-radiotherapy (at least 40 Gy) or short-course radiotherapy combined with chemotherapy
- •Patients aged ≥18 years of age are eligible for inclusion. However, patients aged ≤40 years are recommended to undergo surgery on the theoretical base of a possibly more aggressive tumour disease in this age group, and will be asked to participate in the study by consenting to recording of data. Those patients who insist on W&W approach after careful consideration and well-documented informed consent are eligible for entering the W&W protocol.
- •Given informed consent
- •Stage I-III rectal cancer; however, patients with limited liver metastases who undergo primary liver surgery as part of a "liver first" treatment approach may be included
排除标准
- •Patients without cCR
- •Patients unable to give informed consent
- •Patients with short course radiotherapy (5x5 Gy) without additional chemotherapy, or patients receiving less than 40 Gy in long course CRT
- •Patients with cCR but with increasing tumour growth on MRI after preoperative treatment
- •Patients with metastatic disease at the time of diagnosis with the exception of those who are eligible for "liver first" treatment approach as part of an intention to cure approach.
- •Patients previously diagnosed and treated for malignant disease in the pelvic region with radio- or chemoradiotherapy
- •Other circumstances that may interfere with successful participation in the W&W protocol
结局指标
主要结局
Rate of regrowth
时间窗: Baseline to 5 years
rate of regrowth of tumor after initial complete clinical response (cCR) in patients who undergo a specially designed Watch \& Wait program and without surgical removal of the rectum; to determine the positive predictive value of cCR.
次要结局
- Metachronous distant metastases in patients following the W&W protocol(Baseline to 5 years)
- The rate of cCR after preoperative CRT(Baseline to 5 years)
- Overall and cancer-specific survival protocol compared to patients with ypCR, i.e. patients with complete pathologic response after resection.(Baseline to 5 years)
- Patient-reported outcome measures - rectal function (LARS) and quality of life (QoL)(Baseline to 5 years)
- Patient-reported outcome measures - quality of life (LARS) and quality of life (QoL)(Baseline to 5 years)
- Sensitivity, specificity and overall diagnostic accuracy of MRI with regard to the diagnosis of complete response(Baseline to 5 years)
- Diagnostic accuracy of MRI to detect regrowth during follow-up after complete response(Baseline to 5 years)