Combination Therapy of Anthracyclines for Children With Nephroblastoma

March 25, 2019 updated by: Weisong Cai, Shengjing Hospital

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.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shenjing Hospital
        • Contact:
        • Principal Investigator:
          • Weisong Cai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

June 30, 2045

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (ACTUAL)

March 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJZE001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Dear Sir/Madam Our study receives a grant from China Ministry of Science and Technology. We cannot decide whether the data could be shared. Hope you can understand.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on 0.5-14 Year Old Children With Nephroblastoma

Clinical Trials on Vincristine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe