Study of Tomotherapy HD in Medulloblastoma

NCT ID: NCT03675230

Last Updated: 2018-09-18

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

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-12

Study Completion Date

2020-06-30

Brief Summary

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The aim of the study was to improve local control and long-term survival in children with medulloblastoma, reduce the side effects of treatment and improve quality of life.

Detailed Description

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The technical advantages of Tomotherapy HD in the radiotherapy of children medulloblastoma (advantages in clinical operation and physics) were transformed into clinical advantages, and the possible mechanisms were explored.

Conditions

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Medulloblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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3DCRT

This arm will be planned by 3DCRT to the treatment of the Medulloblastoma

Group Type ACTIVE_COMPARATOR

3DCRT

Intervention Type DEVICE

Patients with Medulloblastoma receiving Three-Dimensional Conformal Radiation Therapy

Tomotherapy HD,TOMO

This arm will be planned by TOMO to the treatment of the Medulloblastoma

Group Type EXPERIMENTAL

Tomotherapy HD

Intervention Type DEVICE

Patients with Medulloblastoma receiving Tomotherapy

Interventions

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Tomotherapy HD

Patients with Medulloblastoma receiving Tomotherapy

Intervention Type DEVICE

3DCRT

Patients with Medulloblastoma receiving Three-Dimensional Conformal Radiation Therapy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The patient was diagnosed as myeloblastoma by surgical pathology with definite pathological classification. MRI of the head and spinal cord before and after operation, with definite staging; Radiotherapy was performed within 28 days after surgery.

Exclusion Criteria

* Previous radiotherapy in the whole brain, whole spinal cord or primary focus; Postoperative radiotherapy for more than 28 days.
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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mawei jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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chuanying zhu, MD

Role: CONTACT

13795327309

Facility Contacts

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Chuanying zhu, MD

Role: primary

862125076994

Other Identifiers

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XH-18-012

Identifier Type: -

Identifier Source: org_study_id

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