Rhabdomyosarcoma, ChildPhase 2NCT05708391
Radiotherapy Combined With Realgar-Indigo Naturalis Formula (RIF) in the Treatment of Rhabdomyosarcoma(RMS) in Children
A Phase 2 study testing Realgar-Indigo Naturalis Formulation and Radiotherapy in people with Rhabdomyosarcoma, Child, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
The goal of this clinical trial]is to evaluate the efficacy, safety and feasibility of radiotherapy combined with Realgar-Indigo naturalis formula（An oral arsenic agent）in the treatment of rhabdomyosarcoma in children. Including the occurrence of adverse events and the improvement of quality of life. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Rhabdomyosarcoma, Child
- What is being tested?
- Realgar-Indigo Naturalis Formulation and Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2023to 30 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Eastern Cooperative Oncology Group performance status score（ECOG PS）: 0-2, and the expected survival time is ≥3 months;
- At least one measurable lesion according to RECIST version 1.1;
- Postoperative pathological diagnosis of rhabdomyosarcoma, pathological staging of Group II-III patients;
- Patients who have not previously received radiotherapy, have received chemotherapy or whose legal guardian refuses to receive chemotherapy, and may have received surgical treatment for the initial diagnosis;
- Normal major organ function, i.e., meeting the following criteria:
- Blood routine examination standards shall meet:(No transfusion within 14 days)
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- Hemoglobin(HB)≥90g/L;
- Absolute Neutrophil Count（ANC）≥1.5×109/L;
- Platelet count(PLT)≥80×109/L
- Biochemical examination shall meet the following standards:
- Bilirubin（BIL）<1.25 times the upper limit of normal (ULN);
- Alaninetransaminase(ALT) and aspartate transaminase（AST）<2.5 ULN;
- Serum creatinine≤1ULN, endogenous creatinine clearance 50ml/min (Cockcroft-Gault formula)
- The subject voluntarily participates in the study, and the patient or legal guardian signs the informed consent form with the consent of the patient, with good compliance and cooperation in follow-up;
- Patients whose physician believes the treatment will benefit.
Who cannot join
- Previous or concurrent with other malignancies;
- Persons who have been proved to be allergic to Realgar-Indigo naturalis formula and/or its excipients;
- Has a number of factors affecting oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.) ;
- Abnormal coagulation function (international normalized ratio(INR) > 1.5, Activated Partial Thromboplastin Time(APTT) > 1.5 uln) , the patients with bleeding tendency (such as active ulcer lesion in stomach, occult blood in stool (+ +) , black stool and/or hematemesis within 3 months, hemoptysis) or the lesion located near the great vessels;
- Tumors involving the skin and/or pharyngeal mucosa with ulceration;
- Have a history of psychotropic substance abuse and can not quit or have mental disorders;
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- patients who had participated in clinical trials of other drugs within 4 weeks;
- The patients whose organ function had not recovered more than 35 days after the previous chemotherapy and could not be treated with the next course of chemotherapy;
- No other anti-cancer treatment may be used during radiotherapy except for the treatment prescribed in the protocol;
- According to the researchers' judgment, there are other patients with concomitant diseases that seriously compromise patient safety or affect the patient's ability to complete the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Concurrent Radiotherapy With Realgar-Indigo Naturalis Formula in the Treatment of Childhood Rhabdomyosarcoma
The goal of this clinical trial]is to evaluate the efficacy, safety and feasibility of radiotherapy combined with Realgar-Indigo naturalis formula（An oral arsenic agent）in the treatment of rhabdomyosarcoma in children. Including the occurrence of adverse events and the improvement of quality of life.
- Conditions
- Rhabdomyosarcoma, Child
- Being tested
- Realgar-Indigo Naturalis Formulation, Radiotherapy
- Medical subject headings
- Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Realgar-Indigo Naturalis FormulationDrug
Radiotherapy: after 4 courses of chemotherapy, radiotherapy was started 13 weeks later. The radiotherapy was performed by three-dimensional conformal intensity modulated radiation (IMRT) technique with a dose of 45-50.4 grey, and radiotherapy was performed 5 times per week for 5-6 weeks.
Oral administration of Realgar-Indigo naturalis formula from 1 week before radiotherapy to the whole radiotherapy period.
Dosage: oral, according to body weight, 3 times a day.Because the patient constitution is different, may first start from the half dose, within 3 days gradually increases the dose.In this study, the dosage of Realgar-Indigo naturalis formula (250mg per tablet) was determined according to the patient's weight stage.In each body weight segment, 60 mg/kg realgar-indigo naturalis formula were given according to the upper limit of body weight
RadiotherapyRadiation
Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm: Radiotherapy, Realgar-Indigo naturalis formula | Experimental | Not described Receives: Drug: Realgar-Indigo Naturalis Formulation; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
It refers to the proportion of patients with tumor shrinkage reaching a certain level and maintaining it for a certain period of time, including CR and PR cases.Objective tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation criteria are divided into complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) according to RECIST 1.1 criteria.
Measured: 1-year
Secondary outcomes (4)
Disease Control Rate
Refers to the percentage of CR, PR and SD (≥4 weeks) cases in evaluable patients.
Measured: 1-year
Overall survival
Refers to the time from the date of patient enrollment to death due to any cause.
Measured: 2-year
Quality of life score
Measured: 1-year
Adverse events
Observe the adverse events occurring in all subjects during the clinical study
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start31 Jan 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhabdomyosarcoma, ChildStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708391
- Sponsor's protocol ID
- XH-23-001
- Status last verified
- Dec 2022
- First submitted
- 18 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Concurrent Radiotherapy With Realgar-Indigo Naturalis Formula in the Treatment of Childhood Rhabdomyosarcoma
- ClinicalTrials.gov ID
- NCT05708391
- Acronym / sponsor ID
- XH-23-001
- Conditions
- Rhabdomyosarcoma, Child
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 31 Jan 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Feb 2023 (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.
The goal of this clinical trial]is to evaluate the efficacy, safety and feasibility of radiotherapy combined with Realgar-Indigo naturalis formula（An oral arsenic agent）in the treatment of rhabdomyosarcoma in children. Including the occurrence of adverse events and the improvement of quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: Radiotherapy, Realgar-Indigo naturalis formula | Experimental | Drug: Realgar-Indigo Naturalis Formulation, Radiation: Radiotherapy |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- Eastern Cooperative Oncology Group performance status score（ECOG PS）: 0-2, and the expected survival time is ≥3 months;
- At least one measurable lesion according to RECIST version 1.1;
- Postoperative pathological diagnosis of rhabdomyosarcoma, pathological staging of Group II-III patients;
- Patients who have not previously received radiotherapy, have received chemotherapy or whose legal guardian refuses to receive chemotherapy, and may have received surgical treatment for the initial diagnosis;
- Normal major organ function, i.e., meeting the following criteria:
Key exclusion criteria (10 listed)
- Previous or concurrent with other malignancies;
- Persons who have been proved to be allergic to Realgar-Indigo naturalis formula and/or its excipients;
- Has a number of factors affecting oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.) ;
- Abnormal coagulation function (international normalized ratio(INR) > 1.5, Activated Partial Thromboplastin Time(APTT) > 1.5 uln) , the patients with bleeding tendency (such as active ulcer lesion in stomach, occult blood in stool (+ +) , black stool and/or hematemesis within 3 months, hemoptysis) or the lesion located near the great vessels;
- Tumors involving the skin and/or pharyngeal mucosa with ulceration;
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 |
|---|---|---|
| Realgar-Indigo Naturalis FormulationRadiotherapy: after 4 courses of chemotherapy, radiotherapy was started 13 weeks later. The radiotherapy was performed by three-dimensional conformal intensity modulated radiation (IMRT) technique with a dose of 45-50.4 grey, and radiotherapy was performed 5 times per week for 5-6 weeks. Oral administration of Realgar-Indigo naturalis formula from 1 week before radiotherapy to the whole radiotherapy period. Dosage: oral, according to body weight, 3 times a day.Because the patient constitution is different, may first start from the half dose, within 3 days gradually increases the dose.In this study, the dosage of Realgar-Indigo naturalis formula (250mg per tablet) was determined according to the patient's weight stage.In each body weight segment, 60 mg/kg realgar-indigo naturalis formula were given according to the upper limit of body weight | Drug | Experimental arm: Radiotherapy, Realgar-Indigo naturalis formula |
| RadiotherapyRadiotherapy | Radiation | Experimental arm: Radiotherapy, Realgar-Indigo naturalis formula |
Primary outcome
Objective response rate
Time frame: 1-year
It refers to the proportion of patients with tumor shrinkage reaching a certain level and maintaining it for a certain period of time, including CR and PR cases.Objective tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation criteria are divided into complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) according to RECIST 1.1 criteria.
4 secondary outcomes
Disease Control Rate
Time frame: 1-year
Overall survival
Time frame: 2-year
Quality of life score
Time frame: 1-year
Adverse events
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Realgar-Indigo Naturalis Formulation and Radiotherapy in people with Rhabdomyosarcoma, Child, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 15 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SiYu Chen, Dr (0086-13651687212, siyu.chen@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 1-year). 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 1 Feb 2023.