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

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ClinicalTrials.gov Identifier: NCT00517959
Recruitment Status : Unknown
Verified June 2012 by Rakesh Jalali, Tata Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 17, 2007
Last Update Posted : December 11, 2012
Terry Fox Foundation
Information provided by (Responsible Party):
Rakesh Jalali, Tata Memorial Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Low Grade Gliomas Craniopharyngioma Ependymomas Meningiomas Radiation: Stereotactic Conformal radiotherapy Radiation: Conventional radiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2001
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: 1
Stereotactic conformal radiotherapy (SCRT)
Radiation: Stereotactic Conformal radiotherapy

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

Primary Outcome Measures :
  1. Incidence of neuropsychological and neuroendocrine function in the two arms

Secondary Outcome Measures :
  1. Progression free and overall survival. [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00517959

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Tata Memorial Centre
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
Terry Fox Foundation
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Principal Investigator: Rakesh Jalali, MD Tata Memorial Hospital
Principal Investigator: Rajiv Sarin, MD FRCR ACTREC, TMC
Publications of Results:
Jalali, Goswami S, Sarin R, More N, Siddha M and Kamble R . Int J of Radiat Oncol Biol Physics 2006;66(4):S14-S19.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rakesh Jalali, Professor, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT00517959    
Other Study ID Numbers: SCRT Trial
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: June 2012
Keywords provided by Rakesh Jalali, Tata Memorial Hospital:
Stereotactic radiotherapy
conformal radiotherapy
late sequelae
endocrine dysfunction
Additional relevant MeSH terms:
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Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases