Combination Therapy of Anthracyclines for Children With Nephroblastoma
NCT ID: NCT03892330
Last Updated: 2019-03-27
Study Results
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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NOT_YET_RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2019-06-01
2045-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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liposomal doxorubicin
Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
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
Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
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.
Doxorubicin
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
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.
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
Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
6 Months
14 Years
ALL
No
Sponsors
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Shengjing Hospital
OTHER
Responsible Party
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Weisong Cai
Professor
Locations
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Shenjing Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SJZE001
Identifier Type: -
Identifier Source: org_study_id
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