0.5-14 Year Old Children With NephroblastomaPhase 4NCT03892330
Combination Therapy of Anthracyclines for Children With Nephroblastoma
A Phase 4 study testing Vincristine, Oxytetracycline/ Cyclophosphamide and Liposomal doxorubicin in people with 0.5-14 Year Old Children With Nephroblastoma, run by Shengjing Hospital at 1 site in China.
Trial summary
This study aims to estimate the efficacy and side effects of study drugs in children with nephroblastoma who are treated with combination therapy. Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- 0.5-14 Year Old Children With Nephroblastoma
- What is being tested?
- Vincristine, Oxytetracycline/ Cyclophosphamide and Liposomal doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 30 Jun 2045
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shenjing Hospital
Shenyang, Liaoning, 110004
Weisong Cai, MD, 86-18940257606, cailab9@hotmail.com
Weisong Cai, MD
About this study
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.
This study aims to estimate the efficacy and side effects of study drugs in children with nephroblastoma who are treated with combination therapy.
- Being tested
- Vincristine, Oxytetracycline/ Cyclophosphamide, Liposomal doxorubicin, Doxorubicin, Pharmorubicin
- Keywords
- Nephroblastoma, Anthracycline, Liposome doxorubicin, Doxorubicin, Pharmorubicin, Pirarubicin
- Medical subject headings
- Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VincristineDrug
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
Oxytetracycline/ CyclophosphamideDrug
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
Liposomal doxorubicinDrug
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.
DoxorubicinDrug
Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
PharmorubicinDrug
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.
PirarubicinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| liposomal doxorubicin | Experimental | Drugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide Receives: Drug: Vincristine; Drug: Oxytetracycline/ Cyclophosphamide; Drug: Liposomal doxorubicin |
| doxorubicin | Active comparator | Drug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide Receives: Drug: Vincristine; Drug: Oxytetracycline/ Cyclophosphamide; Drug: Doxorubicin |
| pharmorubicin | Active comparator | Drug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide Receives: Drug: Vincristine; Drug: Oxytetracycline/ Cyclophosphamide; Drug: Pharmorubicin |
| pirarubicin | Active comparator | Drug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide Receives: Drug: Vincristine; Drug: Oxytetracycline/ Cyclophosphamide; Drug: Pirarubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: 5 years
Time to treatment failure (TTF)
Measured: 5 years
Five-year Event free survival (5-year EFS)
Measured: 5 years
Secondary outcomes (1)
Overall survival (OS)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 0.5-14 Year Old Children With NephroblastomaStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weisong Cai, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892330
- Sponsor's protocol ID
- SJZE001
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03892330
- Acronym / sponsor ID
- SJZE001
- Keywords
- Nephroblastoma, Anthracycline, Liposome doxorubicin, Doxorubicin, Pharmorubicin, Pirarubicin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2045 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to estimate the efficacy and side effects of study drugs in children with nephroblastoma who are treated with combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| liposomal doxorubicin | Experimental | Drug: Vincristine, Drug: Oxytetracycline/ Cyclophosphamide, Drug: Liposomal doxorubicinDrugs: liposome doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide |
| doxorubicin | Active comparator | Drug: Vincristine, Drug: Oxytetracycline/ Cyclophosphamide, Drug: DoxorubicinDrug: doxorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide |
| pharmorubicin | Active comparator | Drug: Vincristine, Drug: Oxytetracycline/ Cyclophosphamide, Drug: PharmorubicinDrug: pharmorubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide |
| pirarubicin | Active comparator | Drug: Vincristine, Drug: Oxytetracycline/ Cyclophosphamide, Drug: PirarubicinDrug: pirarubicin Combination therapy: vincristine and dactinomycin or cyclophosphamide |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VincristineDosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy. | Drug | doxorubicin, liposomal doxorubicin, pharmorubicin, pirarubicin |
| Oxytetracycline/ CyclophosphamideDosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy. | Drug | doxorubicin, liposomal doxorubicin, pharmorubicin, pirarubicin |
| Liposomal doxorubicinThe 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. | Drug | liposomal doxorubicin |
| DoxorubicinDosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy. | Drug | doxorubicin |
| PharmorubicinThe 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. | Drug | pharmorubicin |
| PirarubicinThe dosage of pirarubicin is equal to doxorubicin dosage in Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy. | Drug | pirarubicin |
Primary outcome
Progression free survival (PFS)
Time frame: 5 years
Time to treatment failure (TTF)
Time frame: 5 years
Five-year Event free survival (5-year EFS)
Time frame: 5 years
1 secondary outcome
Overall survival (OS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vincristine, Oxytetracycline/ Cyclophosphamide and Liposomal doxorubicin in people with 0.5-14 Year Old Children With Nephroblastoma, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weisong Cai (18940257606, cailab9@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.