Craniopharyngioma Clinical Trial
— SCRTOfficial 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
Verified date | June 2012 |
Source | Tata Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Institutional Review Board |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | June 2017 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 25 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Tata Memorial Centre | Mumbai | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Tata Memorial Hospital | Terry Fox Foundation |
India,
Jalali, Goswami S, Sarin R, More N, Siddha M and Kamble R . Int J of Radiat Oncol Biol Physics 2006;66(4):S14-S19.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of neuropsychological and neuroendocrine function in the two arms | No | ||
Secondary | Progression free and overall survival. | 5 years | No |
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