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Study of Tomotherapy HD in Medulloblastoma

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ClinicalTrials.gov Identifier: NCT03675230
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Medulloblastoma Device: Tomotherapy HD Device: 3DCRT Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of Tomotherapy HD in Medulloblastoma
Actual Study Start Date : January 12, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 3DCRT
This arm will be planned by 3DCRT to the treatment of the Medulloblastoma
Device: 3DCRT
Patients with Medulloblastoma receiving Three-Dimensional Conformal Radiation Therapy

Experimental: Tomotherapy HD,TOMO
This arm will be planned by TOMO to the treatment of the Medulloblastoma
Device: Tomotherapy HD
Patients with Medulloblastoma receiving Tomotherapy




Primary Outcome Measures :
  1. QoL(quality of life) [ Time Frame: 2 years ]
    Changes in quality of life were assessed by EORTC QLQ-C30


Secondary Outcome Measures :
  1. PFS (progression free survival) [ Time Frame: 2 years ]
    from the first day of therapy to the date of disease progression or death from any cause, whichever was first (according the criterion of RECIST 1.1 ).

  2. OS (overall survival) [ Time Frame: 2 years ]
    from the first day of therapy to death or last follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT03675230


Contacts
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Contact: chuanying zhu, MD 13795327309 zhuchuanying@xinhuamed.com.cn

Locations
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China, Shanghai
The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Chuanying zhu, MD    862125076994    sdnanhai123@163.com   
Principal Investigator: Mawei Jiang, MD         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: mawei jiang, MD Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03675230     History of Changes
Other Study ID Numbers: XH-18-012
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
TOMO irradiation

Additional relevant MeSH terms:
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Medulloblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue