Ambispective Observational Study for Locally Advanced Rectal Cancer Patients Suitable for Wait and Watch (ARROW)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- 1. Successful organ preservation rate
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, investigators 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.
详细描述
The standard treatment options offered to patients of locally advanced rectal cancer are neoadjuvant (treatment given before surgery), radiotherapy & chemotherapy, followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the watch and wait or non-operative management is an option. In this, the patient is monitored after treatment completion. In this study, investigators will only 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. The patient will be followed up, as per standard follow-up protocol, for at least two years after the completion of their treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 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 or LCRT with or without brachytherapy and completed TNT part of treatment till March 2024(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
- •Patients on lost to follow up will be included if they have completed treatment and taking follow up locally, accepting telephonically to participate.
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
时间窗: 3 years.
Percentage of patient avoiding surgery at median of follow up of 3 years.
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire SH22 (Sexual Health)
时间窗: 3 years
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of SH22 (Sexual Health)
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire C30 (Cancer)
时间窗: 3 years
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of C30 (Cancer).
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CR29 (Colorectal)
时间窗: 3 years
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of CR29 (Colorectal).
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire PRT 20 (Proctitis).
时间窗: 3 yeasrs
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of PRT 20 (Proctitis)
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CIPN 20 (Chemotherapy induced peripheral neuropathy).
时间窗: 3 years
Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of CIPN 20 (Chemotherapy induced peripheral neuropathy).
Low Anterior Resection Syndrome Score (LARS)
时间窗: 3 years
The LARS score is a validated and frequently used tool measuring bowel dysfunction after sphincter sparing surgery for rectal cancer. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
International Prostate Symptom Score (IPSS)
时间窗: 3 years
This health tool aims to collect and analyse the perceived symptoms of patients suffering from urinary tract dysfunctions and benign prostatic hyperplasia (BPH)..The overall score in the I-PSS ranges between 0 and 35, from asymptomatic to very symptomatic status.
次要结局
- Total Mesorectal Excision rates(3 years)
- Disease-free survival(3 Years)
- Colostomy-free survival.(3 years)
- Local regrowth rates(3 years)
- Total Mesorectal Excision free survival(3 years)
- Loco-regional control(3 Years)
- Overall survival.(3 years.)
- Treatment-related toxicities(3 years)