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Идёт набор NCT04703101

Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer

Фаза I С лечением Locally Advanced Rectal Carcinoma Rectal Adenocarcinoma Stage II Rectal Cancer AJCC v8 Stage IIA Rectal Cancer AJCC v8

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: Capecitabine, Fluorouracil, Intensity-Modulated Radiation Therapy, Leucovorin.
Кому может быть актуально
Состояния в реестре: Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8. 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 →

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Официальное название

Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX

Обзор

This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.

Подробное описание

PRIMARY OBJECTIVE:

I. Complete clinical response (cCR) rate of patients with clinical T3 and/or node-positive M0 rectal cancer being treated with short-course radiation therapy (SCRT) followed by 16 weeks of modified leucovorin, fluorouracil, and oxaliplatin (mFOLFOX)/capecitabine and oxaliplatin (CapeOX).

SECONDARY OBJECTIVES:

I. 1-year local recurrence free survival and 1-year progression free survival of the entire cohort, the cohort that initially undergoes non-operative management (NOM), and the cohort that initially undergoes total mesorectal excision (TME).

II. Physician-reported acute and late \>= grade 3 toxicity rates. III. 1-year post-treatment patient health-related quality of life and anorectal function as per Patient Reported Outcomes Measurement and Information System (PROMIS).

IV. Explore how Signatera's residual disease test correlates with patient's cCR rates, local recurrence, progression-free, and overall survival rates.

V. Explore radiomics features from longitudinal diffusion weighted magnetic resonance imaging (MRI) (diffusion weighted imaging \[DWI\]) data and build a predictive model for treatment effect (complete response) in rectal cancer patients undergoing SCRT.

OUTLINE:

Patients undergo SCRT in the form of intensity-modulated radiation therapy (IMRT) over 5 fractions daily for 5 consecutive days. Beginning 11-18 days after the last day of radiation therapy, patients receive either oxaliplatin intravenously (IV) and leucovorin IV on day 1 and fluorouracil IV on days 1-3 (mFOLFOX6) or oxaliplatin IV on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14 (CapeOX). Treatment with mFOLFOX6 repeats every 2 weeks for up to 8 cycles, and treatment with CapeOX repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. At 8-12 weeks after completion of all therapy, patients with residual tumor undergo TME. Patients with cCR undergo NOM.

After completion of study treatment, patients who underwent NOM are followed up every 3 months for 2 years, then every 6 months for 3 years. TME patients are followed up every 3-6 months for 2 years, then every 6 months for 3 years.

Вмешательства

  • Препарат Capecitabine
    Given IV
  • Препарат Fluorouracil
    Given IV
  • Лучевая терапия Intensity-Modulated Radiation Therapy
    Undergo IMRT
  • Препарат Leucovorin
    Given IV
  • Препарат Oxaliplatin
    Given IV
  • Другое Quality-of-Life Assessment
    Ancillary studies
  • Поведенческое Surveillance
    Undergo NOM
  • Процедура Total Mesorectal Excision
    Undergo TME

Первичные конечные точки

  • Complete clinical response rate [Срок оценки: Up to 5 years]
Вторичные конечные точки (7)
  • Local recurrence-free survival [Срок оценки: At 1 year]
  • Progression-free survival [Срок оценки: At 1 year]
  • Incidence of adverse events [Срок оценки: Up to 5 years]
  • Health-related quality of life [Срок оценки: At 1 year]
  • Anorectal function [Срок оценки: At 1 year]
  • Signatera's residual disease test [Срок оценки: Up to 5 years]
  • Prediction of complete clinical response rate status by radiomics [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • Histologically confirmed rectal adenocarcinoma
  • Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI
  • No evidence of metastatic disease
  • Resectable primary lesion
  • Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
  • Absolute neutrophil count (ANC) > 1.5 cell/mm\^3
  • Hemoglobin (Hgb) > 8.0 gm/dL
  • Platelets (PLT) > 150,000/mm\^3
  • Total bilirubin < or equal to 1.5 x upper limit of normal
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or equal to three times upper limit of normal
  • If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy

Критерии исключения

  • Active treatment of a separate malignancy
  • Distant metastatic disease as assessed by staging positron emission tomography (PET)/computed tomography (CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Pregnant and/or breastfeeding
  • Medical/psychological contraindication to MRI

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Идентификаторы

NCT: NCT04703101 · 20-001156 · NCI-2020-06479 · 20-001156

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗