0.5-14 Year Old Children With Nephroblastoma
Conditions
Keywords
Nephroblastoma, Anthracycline, Liposome doxorubicin, Doxorubicin, Pharmorubicin, Pirarubicin
Brief summary
This study aims to estimate the efficacy and side effects of study drugs in children with nephroblastoma who are treated with combination therapy.
Interventions
DRUGVincristine
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
DRUGOxytetracycline/ Cyclophosphamide
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
DRUGLiposomal 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.
DRUGDoxorubicin
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
DRUGPharmorubicin
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.
DRUGPirarubicin
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.
Sponsors
Shengjing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 14 Years
Healthy volunteers
No
Inclusion criteria
1. Age 6 months old to 14 years old. 2. No smoking history. 3. Pathologically confirmed nephroblastoma. 4. Informed consent and assent has been obtained before any study assessment is performed. 5. Good compliance. 6. Need to be applied to anthracycline chemotherapy according to the diagnosis and treatment recommendations for Chinese children with nephroblastoma (current version CCCG-WT-2016). 7. Need to be applied to doxorubicin according to the diagnosis and treatment recommendations for children with nephroblastoma (CCCG-WT-2016).
Exclusion criteria
1. Patients with cardiovascular disease in addition to nephroblastoma. 2. Patients with digestive, neurological, circulatory, renal or liver disease, blood disorders or growth abnormalities unrelated to the tumor. 3. Patients have been treated with chemotherapy or cardiotoxic nephrotoxic drugs in the past 4 weeks. 4. Patients have participated in other clinical trials in the past 4 weeks. 5. Patients with mediastinal disease. 6. Patients who have undergone mediastinal radiotherapy due to other tumors or received other treatments that may cause heart damage.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Overall survival (OS) | 5 years |
Countries
China
Contacts
Primary ContactWeisong Cai
Outcome results
None listed