ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
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: Leucovorin, 5-FLUOROURACIL, Oxaliplatin, Irinotecan.
- Кому может быть актуально
- Состояния в реестре: Liver Metastases. Базовые параметры: от 18 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
Обзор
To determine if the detection of ctDNA after surgical resection of CLM can stratify patients into high and low-risk cohorts for early disease recurrence in order to inform post-operative adjuvant therapy.
Подробное описание
Primary Objective:
• To assess 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy
Secondary Objectives:
* To assess recurrence-free survival following liver resection of CLM with curative intent among ctDNA-positive patients * To assess overall survival following liver resection among ctDNA-negative and ctDNA-positive patients * To evaluate the proportion of ctDNA-negative at 1-year post-resection * To compare survival of ctDNA-negative patients undergoing ctDNA-guided postoperative chemotherapy to historical controls * To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement * To delineate the pattern of disease recurrence * To assess ctDNA sensitivity and specificity for predicting disease recurrence * To evaluate MDASI-GI during the course of postoperative therapy * To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection * To evaluate surgery-related adverse events occurring up to 90 days after surgery, and chemo-related adverse events occurring up to 30 days after the last dose of chemotherapy
Outcome Measures:
Primary:
• Recurrence-free survival at 1-year post-hepatectomy among ctDNA-negative patients
Secondary:
* Recurrence-free survival at 1-year post-hepatectomy among ctDNA-positive patients * Overall survival (OS) among ctDNA-negative and ctDNA-positive patients * ctDNA-negativity at 1-year post-resection * Proportion of patients in each group with chemotherapy regimen change in response to ctDNA dynamics * Pattern of disease recurrence (i.e., liver, systemic, salvageable vs. unsalvageable) * ctDNA sensitivity/specificity for recurrent disease overall by timepoint * MDASI-GI at clinic visits during course of postoperative therapy * Tumor radiologic, histologic, and molecular profiling and correlative characterization based upon ctDNA detection * Adverse events
Вмешательства
- Препарат Leucovorin
Given by PO - Препарат 5-FLUOROURACIL
Given by IV - Препарат Oxaliplatin
Given by PO - Препарат Irinotecan
Given by IV - Препарат Capecitabine
Given by IV - Препарат Bevacizumab
Given by IV
Первичные конечные точки
- To establish the 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy [Срок оценки: through study completion, an average of 1 year]
Критерии участия
Критерии включения
- Patients ≥18 years of age with CLM undergoing elective hepatectomy with curative intent (primary colorectal primary cancer previously removed OR being removed at time of hepatectomy) after preoperative chemotherapy (i.e., FOLFOX/FOLFIRI +/- bevacizumab or panitumumab/cetuximab) from 07/01/2021 - 12/31/2023
- Must receive ≥ 4 cycles of preoperative chemotherapy
Критерии исключения
- Patients with primary colorectal tumor that will remain in situ
- Inability to undergo postoperative chemotherapy, or postoperative chemotherapy not planned a priori
- Unwilling/unable to undergo blood draws for ctDNA, patient or provider-determined
- Other active malignancies requiring treatment
- Women who are pregnant
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- M D Anderson Cancer Center — Houston
Идентификаторы
NCT: NCT05062317 · 2021-0584 · NCI-2021-10706