Ambispective Observational Study for Locally Advanced Rectal Cancer Patients Suitable for Wait and Watch Treated with Total Neoadjuvant Therapy (ARROW)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 1. Successful organ preservation rate: percentage of patients avoiding surgery at a median
研究概览
简要总结
One of the standard treatment options offered to patients of locally advanced rectal cancer is neoadjuvant (treatment given before surgery) radiotherapy & chemotherapy followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the wait and watch strategy is also an option. This is another standard treatment option for patients of locally advanced rectal cancers. In this, the patient is monitored after treatment completion. In this study, we are only going to observe the patient’s response to treatment, monitor their side-effects due to treatment and assess their quality of life using standardized quality of life questionnaires. No additional tests or hospital visits will be required as a part of this study. The patient will be followed up, as per standard follow-up protocol, for at least 2 years after the completion of their treatment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years
- •Patients diagnosed with locally advanced rectal cancer and suitable for wait and watch as per international consensus guidelines [3,1]
- •Biopsy-proven adenocarcinoma (non-signet or non-mucinous)
- •T1-4a or N0-2, plus or minus Limited metastatic disease (metastases in 1to 2 organs OR 1to 2 metastases involving a single organ)
- •Non-circumferential disease with CCL less than 7 cm Lower – mid rectum starting upto 7 cm from Anal verge
- •Previously treated with the intent of wait-and-watch with TNT with or without brachytherapy and completed TNT part of treatment (for retrospective cohort)
- •Patients not consenting to ongoing interventional studies, such as the SCOTCH study or any future studies, will be considered and offered
- •Consent to be on standard regular follow-up and answer quality of life questionnaires.
排除标准
- •Not eligible as per the above inclusion criteria.
结局指标
主要结局
1. Successful organ preservation rate: percentage of patients avoiding surgery at a median
时间窗: 3 years
follow up of 3 years
时间窗: 3 years
2. Quality of life outcomes: scored as per standard EORTC manual for various questionnaires.
时间窗: 3 years
次要结局
- Local regrowth rates: Percentage of patients developing local regrowth, earlier deemed complete or near complete clinical response(3 years)
- Total Mesorectal Excision rates: Percentage of patients requiring TME-based surgical management.(3 years)
- Loco-regional control: From the date of start of treatment till the date of local regrowth(3 years)
- Disease-free survival: From the date of start of treatment till the date of diagnosis of disease progression at any site(3 years)
- Overall survival: From the date of start of treatment till the date of death (any cause)(3 years)
- Colostomy-free survival: From the date of start of treatment till the date of permanent(colostomy procedure.)
- Total Mesorectal Excision free survival:From the date of start of treatment till the date of TME-based surgery(3 years)
- Treatment-related toxicities: Acute and late treatment-related Gastro Intestinal, Genito Urinary or any other CTCAE toxicities of grade 3 or higher(3 years)
研究者
Dr Rahul Krishnatry
Tata Memorial Hospital