Pathological Response After Neoadjuvant Treatment on NSCLC
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: Cisplatin, Carboplatin.
- Кому может быть актуально
- Состояния в реестре: Stage IIIA Non-small Cell Lung Cancer. 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
- Испания
- 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
Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes
Обзор
This is a non-interventional, observational, multicenter and retrospective study. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry data base and the data from stage IIIA clinical trials case report forms.
Подробное описание
This is a non-interventional, observational, multicenter and retrospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry (TTR) data base and the data from stage IIIA clinical trials case report forms, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice.
The primary objective is to assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients.
It is estimated that around 15-20 Spanish sites are enrolling patients with these characteristics in the TTR or in the stage IIIA clinical trials of the Fundación GECP.
Pathologists and physician's of these sites will be invited to participate in the PLANET study as all cases will be clinical-pathologically re-evaluated to reach the study objectives. Each pathologist will re-evaluate the specimens from the selected patients under common criteria.The sample size would be 150 patients enrolled in the study.
Вмешательства
- Препарат Cisplatin
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery. - Препарат Carboplatin
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
Первичные конечные точки
- To assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients. [Срок оценки: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months]
Вторичные конечные точки (4)
- To describe the percentage of residual viable tumor in this population of patients under common criteria [Срок оценки: From the end of neoadjuvant treatment until the last follow up or death,assessed up to 45 months]
- To describe the histopathological changes within tumor bed associated to tumor response [Срок оценки: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months]
- To correlate pathological response and post-surgical complications [Срок оценки: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months]
- To describe the relation between nodal downstaging after neoadjuvant treatment and overall survival [Срок оценки: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months]
Критерии участия
Критерии включения
- Patients with resectable stage IIIA disease (according to American Joint Committee on Cancer \[AJCC\] lung cancer edition 7 or 8) who were included in the Tumor Thoracic Registry data base and in stage IIIA clinical trials which the sponsor is Fundación GECP.
- Patients with histologically N2 involvement confirmed
- Patients diagnosed as stage IIIA from 2010 and 2017
- Patients who have received neoadjuvant platinum-based treatment and surgery
- Age ≥ 18 years at time of study entry
- PET /TC at diagnosis
Критерии исключения
- Patients who received chemoradiotherapy neoadjuvant treatment
- Patients who were not resected after neoadjuvant treatment
- Patients who were diagnosed after June 2017
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Испания · 17 центров
- Hospital Universitario De A Coruna — A Coruña
- Hospital General Universitario de Alicante — Alicante
- ICO Badalona, Hospital Germans Trias i Pujol — Badalona
- Hospital Vall d'Hebron — Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona
- ICO Hospitalet — L'Hospitalet de Llobregat
- Hospital Universitario Insular de Gran canaria — Las Palmas de Gran Canaria
- Hospital Dr. Negrín — Las Palmas de Gran Canaria
- … и ещё 9 центров
Идентификаторы
NCT: NCT05167487 · GECP 21/03_PLANET