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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm: Radiotherapy, Realgar-Indigo naturalis formula | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Realgar-Indigo Naturalis Formulation | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | Refers to the percentage of CR, PR and SD (≥4 weeks) cases in evaluable patients. | 1-year |
| Overall survival | Refers to the time from the date of patient enrollment to death due to any cause. |
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Inclusion Criteria:
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)
Biochemical examination shall meet the following standards:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SiYu Chen, Dr | Contact | 0086-13651687212 | siyu.chen@shsmu.edu.cn |
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|
| Radiotherapy | Radiation | Radiotherapy |
|
| 2-year |
| Quality of life score | 1-year |
| Adverse events | Observe the adverse events occurring in all subjects during the clinical study | 1-year |
| ID | Term |
|---|---|
| D012208 | Rhabdomyosarcoma |
| ID | Term |
|---|---|
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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