Combination Therapy of Anthracyclines for Children With Nephroblastoma

NCT03892330 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: SJZE001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

0.5-14 Year Old Children With Nephroblastoma

Keywords

Nephroblastoma; Anthracycline; Liposome doxorubicin; Doxorubicin; Pharmorubicin; Pirarubicin

Outcome Measures

Primary Outcomes (3)

• Progression free survival (PFS)

  5 years

• Time to treatment failure (TTF)

  5 years

• Five-year Event free survival (5-year EFS)

  5 years

Secondary Outcomes (1)

• Overall survival (OS)

  5 years

Study Arms (4)

liposomal doxorubicin

EXPERIMENTAL

Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Drug: Vincristine; Drug: Oxytetracycline/ Cyclophosphamide; Drug: Liposomal doxorubicin

doxorubicin

ACTIVE COMPARATOR

Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Drug: Vincristine; Drug: Oxytetracycline/ Cyclophosphamide; Drug: Doxorubicin

pharmorubicin

ACTIVE COMPARATOR

Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Drug: Vincristine; Drug: Oxytetracycline/ Cyclophosphamide; Drug: Pharmorubicin

pirarubicin

ACTIVE COMPARATOR

Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Drug: Vincristine; Drug: Oxytetracycline/ Cyclophosphamide; Drug: Pirarubicin

Interventions

Vincristine DRUG

Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.

doxorubicin; liposomal doxorubicin; pharmorubicin; pirarubicin

Oxytetracycline/ Cyclophosphamide DRUG

Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.

doxorubicin; liposomal doxorubicin; pharmorubicin; pirarubicin

Liposomal doxorubicin DRUG

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.

liposomal doxorubicin

Doxorubicin DRUG

Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.

doxorubicin

Pharmorubicin DRUG

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.

pharmorubicin

Pirarubicin DRUG

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.

pirarubicin

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shenjing Hospital

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Wilms Tumor

Interventions

Vincristine; Oxytetracycline; Cyclophosphamide; liposomal doxorubicin; Doxorubicin; Epirubicin; pirarubicin

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Weisong Cai

CONTACT

18940257606; cailab9@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2020
• Study Completion (Estimated): June 30, 2045
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

CN (1)