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Combination Therapy of Anthracyclines for Children With Nephroblastoma

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ClinicalTrials.gov Identifier: NCT03892330
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Weisong Cai, 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.

Condition or disease Intervention/treatment Phase
0.5-14 Year Old Children With Nephroblastoma Drug: Vincristine Drug: Oxytetracycline/ Cyclophosphamide Drug: Liposomal doxorubicin Drug: Doxorubicin Drug: Pharmorubicin Drug: Pirarubicin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2045

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Wilms Tumor
Drug Information available for: Doxorubicin

Arm Intervention/treatment
Experimental: liposomal doxorubicin
Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
Drug: Vincristine
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.

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

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.

Active Comparator: doxorubicin
Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
Drug: Vincristine
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.

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

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

Active Comparator: pharmorubicin
Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
Drug: Vincristine
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.

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

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.

Active Comparator: pirarubicin
Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide
Drug: Vincristine
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.

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

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.




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 5 years ]
  2. Time to treatment failure (TTF) [ Time Frame: 5 years ]
  3. Five-year Event free survival (5-year EFS) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892330


Contacts
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Contact: Weisong Cai 18940257606 cailab9@hotmail.com

Locations
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China, Liaoning
Shenjing Hospital Not yet recruiting
Shenyang, Liaoning, China, 110004
Contact: Weisong Cai, MD    86-18940257606    cailab9@hotmail.com   
Principal Investigator: Weisong Cai, MD         
Sponsors and Collaborators
Shengjing Hospital

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Responsible Party: Weisong Cai, Professor, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT03892330     History of Changes
Other Study ID Numbers: SJZE001
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weisong Cai, Shengjing Hospital:
Nephroblastoma
Anthracycline
Liposome doxorubicin
Doxorubicin
Pharmorubicin
Pirarubicin
Additional relevant MeSH terms:
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Wilms Tumor
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Kidney Diseases
Urologic Diseases
Genetic Diseases, Inborn
Dactinomycin
Oxytetracycline
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Vincristine
Pirarubicin
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic