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

NCT00517959 | Unknown Phase 3 DMC

• 1 other identifier: SCRT Trial
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Grade Gliomas; Craniopharyngioma; Ependymomas; Meningiomas

Keywords

Stereotactic radiotherapy; conformal radiotherapy; late sequelae; cognition; endocrine dysfunction

Outcome Measures

Primary Outcomes (1)

• Incidence of neuropsychological and neuroendocrine function in the two arms

Secondary Outcomes (1)

• Progression free and overall survival.

  5 years

Study Arms (2)

1

EXPERIMENTAL

Stereotactic conformal radiotherapy (SCRT)

Radiation: Stereotactic Conformal radiotherapy

2

OTHER

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

Interventions

Stereotactic Conformal radiotherapy RADIATION

SCRT

1

Conventional radiotherapy RADIATION

2

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Previous radiotherapy.
• Planned adjuvant chemotherapy.
• Expected median survival of less than two years.
• Patient not cooperative for planning and execution of SCRT.

Sponsors & Collaborators

• Tata Memorial Hospital: lead
• Terry Fox Foundation: collaborator

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

Location

Related Publications (4)

• Jalali, Goswami S, Sarin R, More N, Siddha M and Kamble R . Int J of Radiat Oncol Biol Physics 2006;66(4):S14-S19.

  RESULT

• Jalali R, Ghosh S, Chatterjee A, Goswami S, Shah N, Dutta D, Krishna U, Gupta T, Goda JS. High-precision radiotherapy achieves excellent long-term control and preserves function in pediatric craniopharyngioma-Subset analysis of a randomized trial. Neuro Oncol. 2025 Sep 17;27(8):2147-2157. doi: 10.1093/neuonc/noaf049.

  PMID: 40056158 DERIVED

• Chatterjee A, Goda JS, Gupta T, Kamble R, Mokal S, Krishnatry R, Sarin R, Jalali R. A randomized trial of stereotactic versus conventional radiotherapy in young patients with low-grade brain tumors: occupational therapy-based neurocognitive data. Neurooncol Adv. 2020 Oct 1;2(1):vdaa130. doi: 10.1093/noajnl/vdaa130. eCollection 2020 Jan-Dec.

  PMID: 33235996 DERIVED

• Jalali R, Gupta T, Goda JS, Goswami S, Shah N, Dutta D, Krishna U, Deodhar J, Menon P, Kannan S, Sarin R. Efficacy of Stereotactic Conformal Radiotherapy vs Conventional Radiotherapy on Benign and Low-Grade Brain Tumors: A Randomized Clinical Trial. JAMA Oncol. 2017 Oct 1;3(10):1368-1376. doi: 10.1001/jamaoncol.2017.0997.

  PMID: 28570730 DERIVED

MeSH Terms

Conditions

Craniopharyngioma; Ependymoma; Meningioma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Glioma; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Officials

• Rakesh Jalali, MD

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Rajiv Sarin, MD FRCR

  ACTREC, TMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 17, 2007
• Study Start: May 1, 2001
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2017
• Last Updated: December 11, 2012

Record last verified: 2012-06

Locations

IN (1)