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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Incidence of neuropsychological and neuroendocrine function in the two arms
- Progression free and overall survival. [ Time Frame: 5 years ]
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
|Tata Memorial Centre|
|Mumbai, Maharashtra, India, 400012|
|Principal Investigator:||Rakesh Jalali, MD||Tata Memorial Hospital|
|Principal Investigator:||Rajiv Sarin, MD FRCR||ACTREC, TMC|