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

Children's Cancer Hospital Egypt 57357

Status: Completed

Conditions: Pediatric Brain Stem Glioma

Treatments: Radiation: Hypofractionated Arm (1); Radiation: Conventional Arm (3); Radiation: Hypofractionated Arm (2)

Study type: Interventional

Funder types: Other

Identifiers

NCT01878266

CCHE-BT002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 3 patient groups

Hypofractionated Arm (1)

Experimental group

Description:

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

Treatment:

Radiation: Hypofractionated Arm (1)

Hypofractionated Arm (2)

Experimental group

Description:

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.

Treatment:

Radiation: Hypofractionated Arm (2)

Conventional Arm (3)

Other group

Description:

The same planning and treatment procedures will be performed with 54.0 Gy in 30 fractions giving 1.8 Gy per fraction.

Treatment:

Radiation: Conventional Arm (3)