NCT00187226

Brief Summary

The purpose of the study was to determine if treating a limited volume of normal tissue surrounding the tumor or tumor bed using conformal radiation therapy would achieve similar rates of disease control compared to standard radiation therapy. The study was also conducted to examine the effect of irradiation on neurological, endocrine and cognitive function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1997

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

August 20, 2012

Completed
9.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

7.8 years

First QC Date

September 13, 2005

Results QC Date

May 4, 2012

Last Update Submit

May 25, 2023

Conditions

Central Nervous System TumorsBrain Tumors

Keywords

Brain neoplasmBrain cancerNeoplasm intracranial

Outcome Measures

Primary Outcomes (1)

  • Local Tumor Control

    Local tumor control was determined by Magnetic Resonance Imaging (MRI) of the brain and spine performed after radiation therapy. Imaging studies were performed every 3-4 months during the first three years and then every 6 months through five years. Imaging studies demonstrating tumor progression were electronically registered to the imaging data used to plan therapy. Local failure included tumor progression within the volume that received the prescribed dose of irradiation.

    12 months after the enrollment of the last therapeutic patient

Study Arms (2)

Stratum 1

OTHER

Ependymoma, craniopharyngioma, low-grade glioma

Procedure: Radiation Therapy

Stratum 2

OTHER

High-grade glioma

Procedure: Radiation Therapy

Interventions

Radiation TherapyPROCEDURE

External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.

Stratum 1

Eligibility Criteria

Age8 Months - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age at time of irradiation is greater than or equal to 8 months and less than or equal to 25 years
  • Histologically diagnosed craniopharyngioma, ependymoma, low-grade astrocytoma or high-grade glioma and radiographically diagnosed selected patients with craniopharyngioma and low-grade glioma.
  • Adequate performance status, participant has an ECOG (Performance Status Score) of 0-2(0=Normal Activity; 1=Symptoms but Ambulatory; 2=Bedridden \<50% of time)
  • Histologic type that requires only focal irradiation.
  • No prior fractionated external beam irradiation
  • Informed consent signed by patient, parent, or guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • Netson KL, Conklin HM, Wu S, Xiong X, Merchant TE. Longitudinal investigation of adaptive functioning following conformal irradiation for pediatric craniopharyngioma and low-grade glioma. Int J Radiat Oncol Biol Phys. 2013 Apr 1;85(5):1301-6. doi: 10.1016/j.ijrobp.2012.10.031. Epub 2012 Dec 11.

    PMID: 23245284DERIVED

Related Links

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Thomas E. Merchant, DO, PhD
Organization
St. Jude Children's Research Hospital
thomas.merchant@stjude.org
901-595-3604

Study Officials

  • Thomas E. Merchant, D.O., Ph.D.

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 1997

Primary Completion

March 31, 2005

Study Completion

February 1, 2022

Last Updated

May 31, 2023

Results First Posted

August 20, 2012

Record last verified: 2023-05

Locations

US(1)