SCRT Versus Conventional RT in Children and Young Adults With Low Grade and Benign Brain Tumors
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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 |
- Incidence of neuropsychological and neuroendocrine function in the two arms [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- Patients with primary intracranial tumours such as low-grade glioma, meningioma, craniopharyngiomas, ependymomas and other benign tumours considered for radical focal radiotherapy.
- Tumours measuring upto 7 cms on maximum dimension on the CT/MRI.
- Age 3 to 25 years.
- NPS of 0-3.
- Informed consent from patients or parents as appropriate.
- Long-term follow up expected
Exclusion Criteria:
- Previous radiotherapy.
- Planned adjuvant chemotherapy.
- Expected median survival of less than two years.
- Patient not cooperative for planning and execution of SCRT.
Contacts and Locations| India | |
| Tata Memorial Centre | |
| Mumbai, Maharashtra, India, 400012 | |
| 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 May 19, 2013