Combination Therapy of Anthracyclines for Children With Nephroblastoma

Официальное название

A Multicenter, Randomized, Double-blind, Prospective Study to Evaluate the Efficacy and Safety of Vincristine, Dactinomycin/Cyclophosphamide Combination Therapy Combined With Liposomal Doxorubicin/Doxorubicin/Pharmorubicin/Pirarubicin in 0.5-14 Year Old Children With Nephroblastoma.

Обзор

This study aims to estimate the efficacy and side effects of study drugs in children with nephroblastoma who are treated with combination therapy.

Вмешательства

• Препарат Vincristine
  Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
• Препарат Oxytetracycline/ Cyclophosphamide
  Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
• Препарат Liposomal doxorubicin
  The dosage of Liposomal doxorubicin is half of doxorubicin dosage in Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
• Препарат Doxorubicin
  Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
• Препарат Pharmorubicin
  The dosage of pharmorubicin is 2 times of doxorubicin dosage in Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
• Препарат Pirarubicin
  The dosage of pirarubicin is equal to doxorubicin dosage in Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.

Первичные конечные точки

• Progression free survival (PFS) [Срок оценки: 5 years]
• Time to treatment failure (TTF) [Срок оценки: 5 years]
• Five-year Event free survival (5-year EFS) [Срок оценки: 5 years]

Вторичные конечные точки (1)

• Overall survival (OS) [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age 6 months old to 14 years old.
• No smoking history.
• Pathologically confirmed nephroblastoma.
• Informed consent and assent has been obtained before any study assessment is performed.
• Good compliance.
• Need to be applied to anthracycline chemotherapy according to the diagnosis and treatment recommendations for Chinese children with nephroblastoma (current version CCCG-WT-2016).
• Need to be applied to doxorubicin according to the diagnosis and treatment recommendations for children with nephroblastoma (CCCG-WT-2016).

Критерии исключения

• Patients with cardiovascular disease in addition to nephroblastoma.
• Patients with digestive, neurological, circulatory, renal or liver disease, blood disorders or growth abnormalities unrelated to the tumor.
• Patients have been treated with chemotherapy or cardiotoxic nephrotoxic drugs in the past 4 weeks.
• Patients have participated in other clinical trials in the past 4 weeks.
• Patients with mediastinal disease.
• Patients who have undergone mediastinal radiotherapy due to other tumors or received other treatments that may cause heart damage.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shenjing Hospital — Шэньян

Идентификаторы

NCT: NCT03892330 · SJZE001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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