Идёт набор NCT06949098

Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer

Фаза II С лечением Rectal Cancer Stage I

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: В протоколе указаны: Local Tumor Resection, Radiotherapy, Chemotherapy.
Кому может быть актуально: Состояния в реестре: Rectal Cancer Stage I. Базовые параметры: 18 лет — 75 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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Официальное название

An Exploratory Study of Local Resection Combined With Chemoradiotherapy in Patients With Low/Ultra-low Early-stage Rectal Cancer With a Strong Desire to Preserve the Anus

Обзор

This study is a single-center, single-arm, prospective clinical trial designed to evaluate the efficacy of local excision followed by postoperative chemoradiotherapy in patients with early-stage low/ultra-low rectal cancer. The study plans to enroll 60 patients with T1-2N0M0 low/ultra-low rectal cancer.

Подробное описание

Baseline examnation: All enrolled patients in this study, in addition to routine laboratory and imaging examinations such as blood routine, blood biochemistry, serum tumor markers (Incl. CEA, CA-199, CA-724 β2-microglobulin, Ferroprotein), chest CT, abdominal and pelvic MRI, etc., were required to undergo KRAS, NRAS, BREF, PD-L1, MMR/MSS testings before surgery, and blood lymphocyte subgroups were analyzed before surgery.

All enrolled patients will first undergo local tumor resection. Adjuvant therapy will be initiated 4-6 weeks postoperatively based on pathological staging:

For pT1N0M0 patients without high-risk features:

Active surveillance OR Radiotherapy alone (Prescription: Pelvic field irradiation 45Gy in 25 fractions)

For pT2N0M0 or pT1N0M0 patients with adverse prognostic factors (including poorly differentiated histology, lymphovascular invasion, positive margins\*, tumor infiltration beyond the outer third of the submucosal muscle layer（SM3 level）, or submucosal invasion \>1mm):

Adjuvant chemoradiotherapy (Prescription:Pelvic field irradiation 45Gy in 25 fractions PLUS Local tumor bed boost 5.4Gy in 3 fractions；Concurrent chemotherapy: Oral capecitabine 825mg/m² twice daily)；For patients with positive margins after local excision: Re-excision followed by adjuvant chemoradiotherapy OR Dose-escalated chemoradiotherapy (Prescription: Pelvic field irradiation 45Gy in 25 fractions PLUS Local tumor bed boost 14.4Gy in 8 fractions)；

For patients with staging \> pT2N0M0:

Total mesorectal excision (TME) Following treatment completion, patients will enter clinical follow-up surveillance.

Вмешательства

Процедура Local Tumor Resection
All enrolled patients will first undergo local tumor resection.
Лучевая терапия Radiotherapy
Pelvic field irradiation 45Gy in 25 fractions plus Local tumor bed boost 5.4Gy in 3 fractions. For patients with positive surgical margins after local resection, a radiotherapy boost (pelvic field 45Gy/25 fractions + tumor bed local boost 14.4Gy/8 fractions) can be given.
Препарат Chemotherapy
Concurrent oral capecitabine 825 mg/m² twice daily with radiotherapy

Первичные конечные точки

5-year DFS Rate [Срок оценки: 5 years]

Вторичные конечные точки (5)

5-year Local Recurrence Rate [Срок оценки: 5 years]
5-year Distant Metastasis Rate [Срок оценки: 5 years]
5-year OS [Срок оценки: 5 years]
Sphincter Retention Rate [Срок оценки: 1 week after sugery]
Quality of Life (QoL) Scores [Срок оценки: 5 years]

Критерии участия

Критерии включения

Age ≥18 years, regardless of gender
ECOG performance status 0-1
Biopsy-proven rectal adenocarcinoma
Distal margin of primary tumor ≤8 cm from anal verge
Clinical stage I (cT1-2N0M0)
Strong organ preservation preference with refusal to undergo abdominoperineal resection (Miles operation)
The surgeon determined a local resection was feasible
No contraindications to chemoradiotherapy