Combination Therapy of Anthracyclines for Children With Nephroblastoma

Sponsor

Shengjing Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03892330

Collaborator

(none)

120

Enrollment

Location

Arms

313

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
0.5-14 Year Old Children With Nephroblastoma	Drug: Vincristine Drug: Oxytetracycline/ Cyclophosphamide Drug: Liposomal doxorubicin Drug: Doxorubicin Drug: Pharmorubicin Drug: Pirarubicin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Jun 30, 2045

Arms and Interventions

Arm	Intervention/Treatment
Experimental: liposomal doxorubicin Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide	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.
Active Comparator: doxorubicin Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide	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: Doxorubicin Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
Active Comparator: pharmorubicin Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide	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: 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.
Active Comparator: pirarubicin Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide	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: 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.

Outcome Measures

Primary Outcome Measures

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

Overall survival (OS) [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.