Combination Therapy of Anthracyclines for Children With Nephroblastoma

NCT ID: NCT03892330

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2045-06-30

Brief Summary

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

Detailed Description

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Conditions

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0.5-14 Year Old Children With Nephroblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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liposomal doxorubicin

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

Group Type EXPERIMENTAL

Vincristine

Intervention Type DRUG

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

Oxytetracycline/ Cyclophosphamide

Intervention Type DRUG

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

Liposomal doxorubicin

Intervention Type 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: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Group Type ACTIVE_COMPARATOR

Vincristine

Intervention Type DRUG

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

Oxytetracycline/ Cyclophosphamide

Intervention Type DRUG

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

Doxorubicin

Intervention Type DRUG

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

pharmorubicin

Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Group Type ACTIVE_COMPARATOR

Vincristine

Intervention Type DRUG

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

Oxytetracycline/ Cyclophosphamide

Intervention Type DRUG

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

Pharmorubicin

Intervention Type 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: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Group Type ACTIVE_COMPARATOR

Vincristine

Intervention Type DRUG

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

Oxytetracycline/ Cyclophosphamide

Intervention Type DRUG

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

Pirarubicin

Intervention Type 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.

Interventions

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Vincristine

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

Intervention Type DRUG

Oxytetracycline/ Cyclophosphamide

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

Intervention Type 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.

Intervention Type DRUG

Doxorubicin

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weisong Cai

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shenjing Hospital

Shenyang, Liaoning, China

Site Status

Countries

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China

Central Contacts

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Weisong Cai

Role: CONTACT

18940257606

Facility Contacts

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Weisong Cai, MD

Role: primary

86-18940257606

Other Identifiers

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SJZE001

Identifier Type: -

Identifier Source: org_study_id

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