Not yet recruiting NCT03892330
Combination Therapy of Anthracyclines for Children With Nephroblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vincristine, Oxytetracycline/ Cyclophosphamide, Liposomal doxorubicin, Doxorubicin.
- Who it may be relevant to
- Registry conditions: 0.5-14 Year Old Children With Nephroblastoma. Basic parameters: 6 months — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
This study aims to estimate the efficacy and side effects of study drugs in children with nephroblastoma who are treated with combination therapy.
Interventions
- Drug Vincristine
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy. - Drug Oxytetracycline/ Cyclophosphamide
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy. - Drug 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. - Drug Doxorubicin
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy. - Drug 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. - Drug 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.
Primary outcome measures
- Progression free survival (PFS) [Time frame: 5 years]
- Time to treatment failure (TTF) [Time frame: 5 years]
- Five-year Event free survival (5-year EFS) [Time frame: 5 years]
Secondary outcome measures (1)
- Overall survival (OS) [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shenjing Hospital — Shenyang
Identifiers
NCT: NCT03892330 · SJZE001