Combination Therapy of Anthracyclines for Children With Nephroblastoma

0.5-14 Year Old Children With Nephroblastoma Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03892330
• Other study ID #: SJZE001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2019
• Est. completion date: June 30, 2045

Study information

• Verified date: March 2019
• Source: Shengjing Hospital
• Contact: Weisong Cai
• Phone: 18940257606
• Email: cailab9[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 30, 2045
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• 0.5-14 Year Old Children With Nephroblastoma
• Wilms Tumor

Intervention

Drug:
• Vincristine
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
• Oxytetracycline/ Cyclophosphamide
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
• 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.
• Doxorubicin
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
• 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.
• 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.

Locations

Country	Name	City	State
China	Shenjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		5 years
Primary	Time to treatment failure (TTF)		5 years
Primary	Five-year Event free survival (5-year EFS)		5 years
Secondary	Overall survival (OS)		5 years