Combination Therapy of Anthracyclines for Children With Nephroblastoma
Phase 4
Not yet recruiting
- Conditions
- 0.5-14 Year Old Children With Nephroblastoma
- Interventions
- Registration Number
- NCT03892330
- Lead Sponsor
- Shengjing Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description liposomal doxorubicin Oxytetracycline/ Cyclophosphamide Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide liposomal doxorubicin Liposomal doxorubicin Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide pharmorubicin Oxytetracycline/ Cyclophosphamide Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide pirarubicin Oxytetracycline/ Cyclophosphamide Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide doxorubicin Oxytetracycline/ Cyclophosphamide Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide doxorubicin Vincristine Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide liposomal doxorubicin Vincristine Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide doxorubicin Doxorubicin Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide pharmorubicin Pharmorubicin Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide pharmorubicin Vincristine Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide pirarubicin Pirarubicin Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide pirarubicin Vincristine Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) 5 years Time to treatment failure (TTF) 5 years Five-year Event free survival (5-year EFS) 5 years
- Secondary Outcome Measures
Name Time Method Overall survival (OS) 5 years
Trial Locations
- Locations (1)
Shenjing Hospital
🇨🇳Shenyang, Liaoning, China