Combination Therapy of Anthracyclines for Children With Nephroblastoma

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

Official Title
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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.

Conditions
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0.5-14 Year Old Children With Nephroblastoma

Intervention / Treatment
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* Drug: Vincristine
* Drug: Oxytetracycline/ Cyclophosphamide
* Drug: Liposomal doxorubicin
* Drug: Doxorubicin
* Drug: Pharmorubicin
* Drug: Pirarubicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: liposomal doxorubicin<br>Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide | Drug: Vincristine<br>* Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.<br>Drug: Oxytetracycline/ Cyclophosphamide<br>* Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.<br>Drug: Liposomal doxorubicin<br>* 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.<br>|
| Active Comparator: doxorubicin<br>Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide | Drug: Vincristine<br>* Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.<br>Drug: Oxytetracycline/ Cyclophosphamide<br>* Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.<br>Drug: Doxorubicin<br>* Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.<br>|
| Active Comparator: pharmorubicin<br>Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide | Drug: Vincristine<br>* Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.<br>Drug: Oxytetracycline/ Cyclophosphamide<br>* Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.<br>Drug: Pharmorubicin<br>* 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.<br>|
| Active Comparator: pirarubicin<br>Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide | Drug: Vincristine<br>* Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.<br>Drug: Oxytetracycline/ Cyclophosphamide<br>* Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.<br>Drug: Pirarubicin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) |  | 5 years | 
| Time to treatment failure (TTF) |  | 5 years | 
| Five-year Event free survival (5-year EFS) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nephroblastoma, Anthracycline, Liposome doxorubicin, Doxorubicin, Pharmorubicin, Pirarubicin