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Ewing SarcomaNCT06451302

Risk Stratification Oriented Treatment of Pediatric Ewing Sarcoma: a Prospective Multicenter Cohort Study

A study testing cyclophosphamide, adriamycin, vincristine，Ifosfamide，etoposide in people with Ewing Sarcoma and Risk Stratification, run by Yizhuo Zhang at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim is to evaluate the outcome and safety of risk-stratification oriented treatment for pediatric Ewing sarcoma in multicenters . Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Ewing Sarcoma, Risk Stratification
What is being tested?
cyclophosphamide, adriamycin, vincristine，Ifosfamide，etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
17 Apr 2024to 31 Dec 2027
Phase
Interventional
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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • age≤18 years, no gender limitation;
  • The ECOG （performance status，PS）is 0～1 score;
  • The expected survival time is not less than 12 weeks;
  • Heart function: A) Cardiac COLOR ultrasound detection LVEF≥ 50%; B) EKG suggests no myocardial ischemia;C) No history of arrhythmia requiring drug intervention before enrollment;
  • Patients who meet the clinical diagnostic criteria and are diagnosed with pediatric Ewing sarcoma;
  • Patients who have progressed, relapsed or refractory after first-line treatment (failed to achieve complete or partial response after recent treatment);
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  • Measurable lesions (according to RECIST 1.1 standards, CT scan length of tumor lesions ≥10mm, CT scan short diameter of lymph node lesions ≥15mm, measurable lesions have not received radiotherapy, freezing and other local treatments);
  • The patient must fully recover from the acute toxic effects of all previous anticancer chemotherapy: A) Myelosuppressive chemotherapy: at least 21 days after the last myelosuppressive chemotherapy (42 days if nitrosourea was used previously);B) Experimental drug or anticancer therapy other than chemotherapy: not available within the first 28 days of planned initiation of AI or VIT. Complete recovery from clinically significant toxicity of the therapy must be determined;C) Hematopoietic growth factor: at least 14 days after the last administration of long-acting growth factor or 3 days after the last administration of short-acting growth factor;D) Immunotherapy: at least 42 days after completion of any type of immunotherapy (except steroids), such as immune checkpoint inhibitors and tumor vaccines; E) X-ray therapy (XRT) : at least 14 days after local palliative XRT (small mouth); For other substantial bone marrow (BM) irradiation, it must be completed for at least 42 days; F) Stem cell infusion without total body irradiation (TBI) : there is no evidence of active graft-versus-host disease and the transplant or stem cell infusion must be completed at least 56 days after the infusion;
  • Laboratory tests during screening should meet the following conditions: A) Absolute value of neutrophils (ANC) ≥1.5×109/L (if bone marrow invasion, ANC≥1.0×109/L); B) Platelet count (PLT) ≥75×109/L (PLT≥50×109/L for bone marrow invasion); C) Bilirubin (sum of combined + uncombined) ≤ 2.5× upper limit of normal value (ULN) (corresponding to age), patients with confirmed Gilbert\'s syndrome can be included in the group according to the investigator\'s judgment; D) Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or serum creatinine (Cr) ≤ 1.5ULN (calculated according to the standard Cockcroft-Gault formula); E) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (5 times ULN if liver metastasis is present)
  • Able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits during the study period;
  • The parent/guardian of the child or adolescent subject is capable of understanding, agreeing to, and signing the study Informed consent (ICF) and the applicable child consent form prior to initiating any program-related procedures; Subject is capable of expressing consent with parental/guardian consent (if applicable).

Who cannot join

  • Patients who have symptomatic brain metastasis except that who completed therapy 21 days prior to enrollment and had stable disease related to brain metastasis confirmed by cerebral CT or MRI or radiography;
  • Previous or concurrent clinical significance of active cardiovascular diseases, including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary heart disease, heart valvular disease, cardiomyopathy, arrhythmias (including persistent atrial fibrillation, complete left bundle branch block, frequent ventricular premature onset); Or prolonged QT interval (QTc) after current corrected heart rate \> 480 ms; Patients with grade III ~ IV cardiac insufficiency according to the New York Heart Association (NYHA) cardiac function classification (age \> 3 years) or infant cardiac function standard (age ≤3 years), or left ventricular ejection fraction (LVEF) \< 50% as indicated by color doppler echocardiography;
  • Patients with a history of pulmonary interstitial disease or concurrent pulmonary interstitial disease;
  • Abnormal coagulation function (INR\>1.5 or prothrombin time (PT)\>ULN+4 seconds or APTT\>1.5 ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant treatment;
  • Severe chronic skin diseases in the past;
  • Previous allergic asthma or severe allergic disease;
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  • Poorly controlled hypertension and diabetes;
  • Have a history of other tumors;
  • HIV or syphilis infected patients;
  • Patients who have previously received organ transplants;
  • Uncontrolled and active systemic bacterial, viral or fungal infection;
  • Contraindications to the use of large doses of hormones, such as uncontrolled hyperglycemia, gastric ulcers or mental diseases;
  • Have a history of severe neurological or psychiatric disorders, including epilepsy or autism.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Prospective Multicenter Cohort Study of Outcome and Safety Profile of Risk Stratification Oriented Treatment in Pediatric Ewing Sarcoma in China

The aim is to evaluate the outcome and safety of risk-stratification oriented treatment for pediatric Ewing sarcoma in multicenters .

Read the detailed description

Pediatric Ewing sarcoma is stratified into three risk groups(low risk, moderate risk and high risk) accordiong to age, longest diameter of lesion, volume and tumor site. Participants receive chemotherapy with corresponding intensity. The prospective study is to assess efficacy, outcome and safety profile of different treatment received for pediatric Ewing sarcoma.

The prospecitive single-arm study is to be conducted in Chinese multicenters.

Being tested
cyclophosphamide, adriamycin, vincristine，Ifosfamide，etoposide
Keywords
risk-stratified treatment
Medical subject headings
Sarcoma, Ewing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cyclophosphamide, adriamycin, vincristine，Ifosfamide，etoposideDrug

    Also called vinorelbine

    The doses and intensity of chemotherapy vary according to risk stratification. Mainenance therapy is added to high-risk patients.

Study groups in NCT06451302
Study groupRoleWhat they receive
Arm Description: Participants receive the straified treatment according to assigned risk groupExperimentalPatients with Ewing sarcoma are risk stratified according to definition. Patients with low risk receive 8 cycles of chemotherapy comprising low-dose cyclosphomide, adriamycin，vincristine(CAV) alternated with ifosfamide and etoposide(IE). Patients with moderate risk receive a total of 12 cycles of moderate-dose CAV and IE. Patients with high risk receive a total of 17 cycles of high-dose CAV and IE. Thereafter, maitenance therapy is administered to high-risk patients after chemotherapy.
Receives: Drug: cyclophosphamide, adriamycin, vincristine，Ifosfamide，etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    The proportion of patients who achieved CR or PR

    Measured: from initial diagnosis to 5 years after EOT

Secondary outcomes (2)

  1. OS

    The time from from start of treatment to death or loss of follow-up

    Measured: from start of treatment to 5 years after EOT

  2. EFS

    The time from from start of treatment to disease progression, recurrence

    Measured: from start of treatment to 5 years after EOT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start17 Apr 2024
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06451302
Sponsor's protocol ID
SunYat-senU-Ewing sarcoma
Status last verified
Jun 2024
First submitted
2 Jun 2024
Last updated
11 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing cyclophosphamide, adriamycin, vincristine，Ifosfamide，etoposide in people with Ewing Sarcoma and Risk Stratification, run by Yizhuo Zhang 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 11 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2024. 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: from initial diagnosis to 5 years after EOT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06451302.

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 11 Jun 2024.

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