Combination Therapy of Anthracyclines for Children With Nephroblastoma

China Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: 0.5-14 Year Old Children With Nephroblastoma

Treatments: Drug: Oxytetracycline/ Cyclophosphamide; Drug: Liposomal doxorubicin; Drug: Pirarubicin; Drug: Vincristine; Drug: Pharmorubicin; Drug: Doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT03892330

SJZE001

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 6 months to 14 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

liposomal doxorubicin

Experimental group

Description:

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

Treatment:

Drug: Liposomal doxorubicin

Drug: Vincristine

Drug: Oxytetracycline/ Cyclophosphamide

doxorubicin

Active Comparator group

Description:

Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Treatment:

Drug: Doxorubicin

Drug: Vincristine

Drug: Oxytetracycline/ Cyclophosphamide

pharmorubicin

Active Comparator group

Description:

Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Treatment:

Drug: Pharmorubicin

Drug: Vincristine

Drug: Oxytetracycline/ Cyclophosphamide

pirarubicin

Active Comparator group

Description:

Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide

Treatment:

Drug: Pirarubicin

Drug: Vincristine

Drug: Oxytetracycline/ Cyclophosphamide