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Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

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ClinicalTrials.gov Identifier: NCT01878266
Recruitment Status : Unknown
Verified January 2016 by Children's Cancer Hospital Egypt 57357.
Recruitment status was:  Recruiting
First Posted : June 14, 2013
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Children's Cancer Hospital Egypt 57357

Brief Summary:
This Trial offers a reduction in patient burden, which is especially preferable in children with a poor compliance and poor performance status. This prospective randomized trial was extension to the previous controlled prospective study performed in Children's Cancer Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this work is to demonstrate noninferiority of the hypofractionated regimens relative to the conventional regimen in a controlled randomized clinical study.

Condition or disease Intervention/treatment Phase
Pediatric Brain Stem Glioma Radiation: Hypofractionated Arm (1) Radiation: Hypofractionated Arm (2) Radiation: Conventional Arm (3) Phase 3

Detailed Description:
In this study will add a third arm in which we will increase in the total dose to 4500 cGy in 15 fractions in 3 weeks may lead to improvement in Over-all survival or Progression-Free Survival.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma
Study Start Date : February 2013
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016


Arm Intervention/treatment
Active Comparator: Hypofractionated Arm (1)
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week , by conformal radiotherapy sparing of the supratentorial brain. The planning target volume included the tumor as defined by the T2-weighted MRI images with a margin of 1.5-2.0 cm. Margins were adjusted for bony structures and tentorium. With exception of steroids, no neoadjuvant, concomitant, or adjuvant systemic treatment was allowed
Radiation: Hypofractionated Arm (1)
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week

Active Comparator: Hypofractionated Arm (2)
The same planning and treatment procedures will be performed. The total dose will be 4500 cGy in 15 fractions in 3 weeks; giving 300 cGy per fraction.
Radiation: Hypofractionated Arm (2)
The total dose to 4500 cGy in 15 fractions in 3 weeks

Conventional Arm (3)
The same planning and treatment procedures will be performed with 54.0 Gy in 30 fractions giving 1.8 Gy per fraction.
Radiation: Conventional Arm (3)
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm




Primary Outcome Measures :
  1. Median overall-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 years ]


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed patients with a diffuse intrinsic brainstem glioma
  2. Aged 2-18years,
  3. Have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs.
  4. No performance criteria were required for entry onto the study.

Exclusion Criteria:

  • Children were not eligible if they had received any prior therapy other than steroids Treatment

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): NCT01878266


Contacts
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Contact: Mohamed S Zaghloul, MD (202)25351500 ext 1192 mszagh@yahoo.com
Contact: Wafaa M Rashed, Pharm b 202-25351500 ext 7209 waffa.rashed@57357.com

Locations
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Egypt
Children's Cancer Hospital Egypt 57357 Recruiting
Cairo, Egypt, 11441
Contact: Mohamed S zaghloul, MD    202-25351500 ext 1192    mszagh@yahoo.com   
Principal Investigator: Mohamed S Zaghloul, MD         
Sponsors and Collaborators
Children's Cancer Hospital Egypt 57357

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Responsible Party: Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier: NCT01878266     History of Changes
Other Study ID Numbers: CCHE-BT002
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Keywords provided by Children's Cancer Hospital Egypt 57357:
Diffuse Intrinsic Pontine Glioma (DIPG)
Hypofractionated Radiotherapy
Radiotherapy
Median survival
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue