SCRT Versus Conventional RT in Children and Young Adults With Low Grade and Benign Brain Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Terry Fox Foundation
Information provided by (Responsible Party):
Rakesh Jalali, Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00517959
First received: August 16, 2007
Last updated: December 8, 2012
Last verified: June 2012
  Purpose

Brain tumours are the commonest solid tumours in children and the second most common neoplasms overall in this patient population. Radiotherapy plays an important part in the management in a majority of these tumours. While the cure rates of these tumours, especially the benign and low grade ones are quite encouraging, the treatment itself may lead to some late sequelae, which could have significant implications in the quality of life in these long-term survivors.

Stereotactic conformal radiotherapy (SCRT) is a modern high-precision radiotherapy technique, which reduces the volume of normal brain irradiated and has the capability to minimise the doses to critical structures. The present study is designed to prospectively estimate the incidence and severity of neuropsychological, cognitive and neuroendocrine dysfunction following radiotherapy delivered with conventional and stereotactic techniques and would be one of the most comprehensive studies providing very important longitudinal and reliable data regarding these sequelae. The study involving 200 patients would be to the best of our knowledge not only the largest ever study conducted so far but also the only randomised trial assessing these sequelae in patients receiving focal brain irradiation.

The study also examines whether the physical advantages of modern technological progress translate in clinical benefit. This could have significant implications in the radiotherapeutic management of children and young adults with brain tumours. The study is unique in design in terms of evaluating the efficacy of SCRT with respect to conventional radiotherapy in terms of long term tumour control and treatment related complications.


Condition Intervention Phase
Low Grade Gliomas
Craniopharyngioma
Ependymomas
Meningiomas
Radiation: Stereotactic Conformal radiotherapy
Radiation: Conventional radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Stereotactic Conformal Radiotherapy (SCRT) Compared to Conventional Radiotherapy in Minimising Late Sequelae in Children and Young Adults With Brain Tumours: a Randomised Clinical Trial

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Incidence of neuropsychological and neuroendocrine function in the two arms [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free and overall survival. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: May 2001
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Stereotactic conformal radiotherapy (SCRT)
Radiation: Stereotactic Conformal radiotherapy
SCRT
2
Conventional radiotherapy Patients in this arm will be treated with conventional radiotherapy techniques being used at the moment in the department. This involves patient being immobilised with a customised thermoplastic mask after which they will have a contrast enhanced planning CT scan. The radiation oncologist will draw the tumour on the appropriate CT slices and a margin of 1-2 cms grown for the planning target volume. Beam arrangement will be relatively simple and typically consist of 2-3 coplanar fields using 6 MV photons. Conventional planning optimisation will be carried out by the use of wedges, beam weightage and corner shields as appropriate. Radiotherapy doses, prescription and fractionation schedules will be identical to the SCRT arm
Radiation: Conventional radiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with primary intracranial tumours such as low-grade glioma, meningioma, craniopharyngiomas, ependymomas and other benign tumours considered for radical focal radiotherapy.
  2. Tumours measuring upto 7 cms on maximum dimension on the CT/MRI.
  3. Age 3 to 25 years.
  4. NPS of 0-3.
  5. Informed consent from patients or parents as appropriate.
  6. Long-term follow up expected

Exclusion Criteria:

  1. Previous radiotherapy.
  2. Planned adjuvant chemotherapy.
  3. Expected median survival of less than two years.
  4. Patient not cooperative for planning and execution of SCRT.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517959

Locations
India
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
Terry Fox Foundation
Investigators
Principal Investigator: Rakesh Jalali, MD Tata Memorial Hospital
Principal Investigator: Rajiv Sarin, MD FRCR ACTREC, TMC
  More Information

No publications provided

Responsible Party: Rakesh Jalali, Professor, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00517959     History of Changes
Other Study ID Numbers: SCRT Trial
Study First Received: August 16, 2007
Last Updated: December 8, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Tata Memorial Hospital:
Stereotactic radiotherapy
conformal radiotherapy
late sequelae
cognition
endocrine dysfunction

Additional relevant MeSH terms:
Brain Neoplasms
Craniopharyngioma
Adamantinoma
Ependymoma
Glioma
Meningioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Neoplasms, Vascular Tissue
Meningeal Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014