Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-25

Study Completion Date

2018-08-29

Brief Summary

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The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.

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Detailed Description

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Subjects will receive GRID radiotherapy. GRID radiation therapy is considered a standard radiation therapy method however is not typically used in pediatric osteosarcoma patients. This protocol will evaluate whether or not the use of this therapy will provide benefit to this patient population.

Conditions

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Osteosarcoma in Children Radiation Toxicity

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GRID Radiotherapy

Patients will be treated with GRID Radiotherapy

Group Type EXPERIMENTAL

GRID radiotherapy

Intervention Type RADIATION

Patients will be treated with GRID radiotherapy

Interventions

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GRID radiotherapy

Patients will be treated with GRID radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* History of cytological or histological documentation of non-metastatic extremity osteosarcoma.
* 5-21 years of age.
* Subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma
* Informed consent is obtained