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NCT Number: NCT03892330

Combination Therapy of Anthracyclines for 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.

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Key information

Conditions

0.5-14 Year Old Children With Nephroblastoma Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplastic Syndromes, Hereditary Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Wilms Tumor

Age range

6 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shenjing Hospital

Shenyang, Liaoning, 110004, China

Location contact

Weisong Cai, MD

CONTACT

[email protected]

86-18940257606

Weisong Cai, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vincristine

Drug

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

Oxytetracycline/ Cyclophosphamide

Drug

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

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.

Doxorubicin

Drug

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

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.

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.

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: 5 years

  2. Time to treatment failure (TTF)

    Time frame: 5 years

  3. Five-year Event free survival (5-year EFS)

    Time frame: 5 years

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Weisong Cai

CONTACT

[email protected]

18940257606

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2045
First posted
Mar 27, 2019
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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