NCT05708391

Radiotherapy Combined With Realgar-Indigo Naturalis Formula (RIF) in the Treatment of Rhabdomyosarcoma(RMS) in Children

Efficacy and Safety of Concurrent Radiotherapy With Realgar-Indigo Naturalis Formula in the Treatment of Childhood Rhabdomyosarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhabdomyosarcoma, Child

Interventions

Type	Name	Description
DRUG	Realgar-Indigo Naturalis Formulation	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
RADIATION	Radiotherapy	Radiotherapy

Timeline

• Start date: 2023-01-31
• Primary completion: 2024-03-31
• Completion: 2024-12-30
• First posted: 2023-02-01
• Last updated: 2023-02-01