Efficacy and Safety of Radiotherapy Combined With Apatinib Mesylate in the Treatment of Rhabdomyosarcoma in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-04-01

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of radiotherapy combined with apatinib mesylate in the treatment of rhabdomyosarcoma in children.

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Detailed Description

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This study is a Interventional study. The target group was 3-18 years old, and the pathological stage was group II-IV recurrence or distant metastasis. A total of 48 patients were enrolled in this study. The treatment was radiotherapy combined with apatinib. The main outcome measures were ORR, DCR , OS , quality of life and drug safety. The main safety indicators were vital signs, laboratory indicators, adverse events (AE), and severe adverse events (SAE). This study is expected to be enrolled for 6 months.

Conditions

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Childhood Rhabdomyosarcoma

Study Design

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Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Apatinib mesylate tablets

Intervention Type DRUG

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)

Three-dimensional conformal intensity modulation

Intervention Type RADIATION

Three-dimensional conformal intensity modulation (IMRT) technique was used for post-operative radiotherapy. The radiation dose was 45-54 Gy.

Interventions

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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)

Intervention Type DRUG

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.

Intervention Type RADIATION

Other Intervention Names

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3D-IMRT

Eligibility Criteria

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Inclusion Criteria

* Patients must be ≥ 3 and ≤ 18 years of age.
* The predicted survival period is more than 3 months.
* According to RECIST version 1.1, there is at least one measurable lesion.
* Postoperative pathological stage was group II-IV.
* Patients have not received radiotherapy before, and can accept chemotherapy and surgical treatment.
* No other anticancer therapy should be used during radiotherapy.
* The main organs are functioning normally, which meets the following criteria:

1. Blood routine examination standards should be met: (no blood transfusion within 14 days) A.HB\>90g/L; B.ANC\>1.5\*109/L; C.PLT\>80\*109/L
2. Biochemical tests should meet the following criteria:

A. BIL \< 1.25 times normal upper limit (ULN); B. ALT and AST \< 2.5 ULN; C. Serum Cr \< 1 ULN, endogenous creatinine clearance \> 50 ml/min

* Subjects volunteered to participate in this study, patients or legal guardians signed informed consent through patient consent, good compliance, with follow-up.
* Doctors believe that treatment can benefit patients.

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No