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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
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
Radiotherapy
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.
Time frame: 1-year
Disease Control Rate
Refers to the percentage of CR, PR and SD (≥4 weeks) cases in evaluable patients.
Time frame: 1-year
Overall survival
Refers to the time from the date of patient enrollment to death due to any cause.
Time frame: 2-year
Quality of life score
Time frame: 1-year
Adverse events
Observe the adverse events occurring in all subjects during the clinical study
Time frame: 1-year
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