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Идёт набор NCT07260526

Response-adapted Total Neoadjuvant Therapy Guided by Induction Chemotherapy in Early- and Intermediate-risk Low Rectal Cancer for Implementation of a Watch-and-wait Strategy

— Наблюдательное Rectal Cancer

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 Cancer. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study investigates the feasibility of an organ-preserving "watch-and-wait" strategy in patients with mid-to-low rectal cancer who achieve a good response after total neoadjuvant therapy (TNT). By retrospectively and prospectively analyzing patients who complete TNT following effective induction chemotherapy, the study aims to assess organ preservation rates and evaluate whether non-surgical management can provide comparable oncologic outcomes to radical surgery while improving functional recovery and quality of life.

Подробное описание

With the evolution of rectal cancer treatment concepts, achieving optimal oncologic outcomes while preserving organ function and improving patients' quality of life has become a major goal in the management of low rectal cancer. Multiple studies have reported that for patients who achieve a clinical complete response (cCR) after total neoadjuvant therapy (TNT), a watch-and-wait (organ preservation) strategy-with close follow-up and salvage surgery when necessary-yields 5-year disease-free survival (DFS) and overall survival (OS) rates comparable to those of patients who undergo radical surgery and achieve a pathological complete response (pCR). Moreover, compared with total mesorectal excision (TME), patients managed with a watch-and-wait approach demonstrate significantly better physical, cognitive, role, and social-emotional functioning, along with lower incidences of bowel, sexual, and urinary dysfunction.

This study aims to retrospectively and prospectively include patients with mid-to-low rectal cancer who respond well to induction chemotherapy and subsequently complete TNT, in order to observe the organ preservation rate after TNT and to preliminarily evaluate the feasibility of this treatment approach within a watch-and-wait strategy.

Первичные конечные точки

  • 1-year organ preservation rate [Срок оценки: 1 year after completion of neoadjuvant radiotherapy]
Вторичные конечные точки (2)
  • 1-year metastasis-free survival [Срок оценки: 1 year after total neoadjuvant therapy]
  • 1-year overall survival [Срок оценки: 1 year after total neoadjuvant therapy]

Критерии участия

Критерии включения

  • Age: 18-80 years; no restriction on sex.
  • Histologically confirmed rectal adenocarcinoma with immunohistochemistry and/or genetic testing showing pMMR/MSS status.
  • Tumor characteristics assessed by chest-abdominal CT, rectal ultrasound, and MRI meeting all of the following criteria:
  • The lower edge of the tumor is ≤5 cm from the anal verge as measured by digital rectal examination or MRI;
  • Clinical stage cT1-3abN0-1M0 (for cT1N0, patients suitable for endoscopic resection are excluded);
  • MRF (-) (>1 mm), EMVI (±);
  • Negative lateral lymph nodes and <7 mm in size;
  • Maximum tumor length ≤5 cm;
  • Tumor circumference involvement ≤2/3.
  • After receiving at least two cycles of induction chemotherapy with the XELOX regimen, MRI assessment shows treatment response (tumor length reduced by ≥30% compared with baseline).
  • Completion of total neoadjuvant therapy (TNT), including long-course chemoradiotherapy and consolidation chemotherapy (radiotherapy: 25-28 fractions; chemotherapy: 6-8 cycles).
  • (For the prospective cohort) Provision of written informed consent for participation in this observational study.

Критерии исключения

  • Patients with a history of, or concurrent, other malignant tumors (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
  • Patients with severely incomplete clinical data that preclude effective evaluation;
  • (For the prospective cohort) Patients who refuse to provide written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • West China hospital, Sichuan University — Чэнду

Идентификаторы

NCT: NCT07260526 · WCH20250924

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗