Идёт набор NCT06252142

Study for Wait and Watch Suitable in Rectal Cancer

— Наблюдательное Rectal Neoplasms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Rectal Neoplasms. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Индия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Ambispective Observational Study for Locally Advanced Rectal Cancer Patients Suitable for Wait and Watch (ARROW)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

1. Successful organ preservation rate [Срок оценки: 3 years.]
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CR29 (Colorectal) [Срок оценки: 3 years]
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire C30 (Cancer) [Срок оценки: 3 years]
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire SH22 (Sexual Health) [Срок оценки: 3 years]
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire PRT 20 (Proctitis). [Срок оценки: 3 yeasrs]
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CIPN 20 (Chemotherapy induced peripheral neuropathy). [Срок оценки: 3 years]
Low Anterior Resection Syndrome Score (LARS) [Срок оценки: 3 years]
International Prostate Symptom Score (IPSS) [Срок оценки: 3 years]

Вторичные конечные точки (8)

Local regrowth rates [Срок оценки: 3 years]
Total Mesorectal Excision rates [Срок оценки: 3 years]
Loco-regional control [Срок оценки: 3 Years]
Disease-free survival [Срок оценки: 3 Years]
Overall survival. [Срок оценки: 3 years.]
Colostomy-free survival. [Срок оценки: 3 years]
Total Mesorectal Excision free survival [Срок оценки: 3 years]
Treatment-related toxicities [Срок оценки: 3 years]

Критерии участия

Критерии включения

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.