Efficacy and Safety of Radiotherapy Combined With Apatinib Mesylate in the Treatment of Rhabdomyosarcoma in Children
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|ClinicalTrials.gov Identifier: NCT03868852|
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Childhood Rhabdomyosarcoma||Drug: Apatinib mesylate tablets Radiation: Three-dimensional conformal intensity modulation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Simons two-stage design method requires the enrollment of 13 patients in the first stage. If more than 7 patients fail to reach the expected end point, the first stage fails and the patients do not need to enter the second stage. A total of 48 patients were enrolled. If more than 30 patients did not reach the expected end point, the overall trial failed.|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Radiotherapy Combined With Apatinib Mesylate in the Treatment of Rhabdomyosarcoma in Children|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||April 1, 2020|
Experimental: Radiotherapy plus apatinib mesylate
All eligible patients signed informed consent. Three-dimensional conformal intensity modulation (IMRT) technique was used to treat the patients with radiation doses 45 Gy - 54 Gy. All patients took apatinib mesylate tablets 250 mg QD orally from 1 week before radiotherapy to the whole radiotherapy period. They were required to take apatinib mesylate tablets with warm boiling water half an hour after meal. The daily medication time should be as consistent as possible.
Drug: Apatinib mesylate tablets
Apatinib mesylate tablets were orally administered 250 mg QD from 1 week before radiotherapy to the whole radiotherapy period. (Appatinib is no longer used after radiotherapy)
Radiation: Three-dimensional conformal intensity modulation
Three-dimensional conformal intensity modulation (IMRT) technique was used for post-operative radiotherapy. The radiation dose was 45-54 Gy.
Other Name: 3D-IMRT
- Objective response rate (ORR) [ Time Frame: First analysis will occur 1 month after accrual of all patients. ]Refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained for a certain period of time, including CR and PR cases. Objective remission of solid tumors was assessed by RECIST 1.1. Subjects must be accompanied by measurable tumor lesions at baseline. According to RECIST 1.1, the criteria for evaluating efficacy are complete remission (CR), partial remission (PR), stability (SD), and progression (PD).
- Disease Control Rate (DCR) [ Time Frame: First analysis will occur 1 month after accrual of all patients. ]The percentage of patients whose tumors shrink or remain stable for a certain period of time
- Total Survival (OS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. ]The time from enrollment to death for any reason. For those who had lost interviews before death, the last follow-up time was usually calculated as the time of death.
- Quality of Life Score [ Time Frame: Weekly assessment , assessed up to 1 month. ]
Quality of life score refer to EORTC qlq-c30 (version 3, Chinese version). Quality of Life Questionnare-Core 30 prepared by The European O-rganization for Reasearch and Treatment of Cancer.
EORTC qlq-c30 (V3.0) is the core scale for all cancer patients, with a total of 30 items. Items 29 and 30 are rated on a scale of 1 to 7 according to their answer choices. The other items are divided into four levels: totally not, a little bit, a lot and very much, and are scored on a scale of 1 to 4.
The higher the score of functional domain and general health domain, the better the functional status and quality of life. The higher the score of symptom domain, the more symptoms or problems (the worse the quality of life).
- Incidence and severity of Adverse Events [ Time Frame: From date of enrollment until 30 days after the last medication. ]The safety of the drug was evaluated by NCI-CTCAE 4.0. Common Terminology Criteria Adverse Events Version 4.0 prepared by National Cancer Institute.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868852
|Contact: Mawei Jiang, MDfirstname.lastname@example.org|
|Contact: Chuanying Zhu, MDemail@example.com|
|The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200092|
|Contact: Mawei Jiang, MD 02125078635 firstname.lastname@example.org|
|Principal Investigator: Mawei Jiang, MD|
|Principal Investigator:||Mawei Jiang, MD||Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine|