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Combination Therapy of Anthracyclines for Children With Nephroblastoma

Primary Purpose

0.5-14 Year Old Children With Nephroblastoma

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vincristine
Oxytetracycline/ Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Pharmorubicin
Pirarubicin
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 0.5-14 Year Old Children With Nephroblastoma focused on measuring Nephroblastoma, Anthracycline, Liposome doxorubicin, Doxorubicin, Pharmorubicin, Pirarubicin

Eligibility Criteria

6 Months - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shenjing Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

liposomal doxorubicin

doxorubicin

pharmorubicin

pirarubicin

Arm Description

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

Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
Time to treatment failure (TTF)
Five-year Event free survival (5-year EFS)

Secondary Outcome Measures

Overall survival (OS)

Full Information

First Posted
March 25, 2019
Last Updated
March 25, 2019
Sponsor
Shengjing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03892330
Brief Title
Combination Therapy of Anthracyclines for Children With Nephroblastoma
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 30, 2045 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
0.5-14 Year Old Children With Nephroblastoma
Keywords
Nephroblastoma, Anthracycline, Liposome doxorubicin, Doxorubicin, Pharmorubicin, Pirarubicin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
liposomal doxorubicin
Arm Type
Experimental
Arm Description
Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
Arm Title
doxorubicin
Arm Type
Active Comparator
Arm Description
Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
Arm Title
pharmorubicin
Arm Type
Active Comparator
Arm Description
Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
Arm Title
pirarubicin
Arm Type
Active Comparator
Arm Description
Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Oxytetracycline/ Cyclophosphamide
Intervention Description
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Liposomal doxorubicin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Pharmorubicin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pirarubicin
Intervention Description
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 Outcome Measure Information:
Title
Progression free survival (PFS)
Time Frame
5 years
Title
Time to treatment failure (TTF)
Time Frame
5 years
Title
Five-year Event free survival (5-year EFS)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weisong Cai
Phone
18940257606
Email
cailab9@hotmail.com
Facility Information:
Facility Name
Shenjing Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weisong Cai, MD
Phone
86-18940257606
Email
cailab9@hotmail.com
First Name & Middle Initial & Last Name & Degree
Weisong Cai, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

Combination Therapy of Anthracyclines for Children With Nephroblastoma

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