Central Nervous System TumorsPhase 2NCT00187226
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
A Phase 2 study testing Radiation Therapy in people with Central Nervous System Tumors and Brain Tumors, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 months to 25 years
- Conditions the study is for
- Central Nervous System Tumors, Brain Tumors
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1997to 1 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 months to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects
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.
Read the detailed description
Radiation therapy is commonly used to treat a variety of brain tumors in children including ependymoma, craniopharyngioma and low- and high-grade glioma. The ability of the therapy to control brain tumors in children is known to depend on the tumor type, extent of resection and other clinical factors. Children who received radiation therapy on this study were evaluated for treatment failure at 12 months. In addition to the primary objective, the study was designed to explore the association between radiation dose and volume and a variety of neurological, endocrine and cognitive deficits up to 5 years after treatment.
- Conditions
- Central Nervous System Tumors, Brain Tumors
- Being tested
- Radiation Therapy
- Keywords
- Brain neoplasm, Brain cancer, Neoplasm intracranial
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyProcedure or surgery
External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.
Radiation TherapyProcedure or surgery
External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1 | Other | Ependymoma, craniopharyngioma, low-grade glioma Receives: Procedure: Radiation Therapy |
| Stratum 2 | Other | High-grade glioma Receives: Procedure: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the enrollment of the last therapeutic patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 1997
- Primary completion31 Mar 2005
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas E. Merchant, D.O., Ph.D., Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187226
- Sponsor's protocol ID
- RT1
- Status last verified
- May 2023
- First submitted
- 13 Sep 2005
- Last updated
- 31 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23245284
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects
- ClinicalTrials.gov ID
- NCT00187226
- Acronym / sponsor ID
- RT1
- Conditions
- Central Nervous System Tumors, Brain Tumors
- Keywords
- Brain neoplasm, Brain cancer, Neoplasm intracranial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Jun 1997 (actual)
- Primary completion
- 31 Mar 2005 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 20 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Radiation therapy is commonly used to treat a variety of brain tumors in children including ependymoma, craniopharyngioma and low- and high-grade glioma. The ability of the therapy to control brain tumors in children is known to depend on the tumor type, extent of resection and other clinical factors. Children who received radiation therapy on this study were evaluated for treatment failure at 12 months. In addition to the primary objective, the study was designed to explore the association between radiation dose and volume and a variety of neurological, endocrine and cognitive deficits up to 5 years after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratum 1 | Other | Procedure: Radiation TherapyEpendymoma, craniopharyngioma, low-grade glioma |
| Stratum 2 | Other | Procedure: Radiation TherapyHigh-grade glioma |
Who may qualify
- Ages
- 8 months to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyExternal Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma. | Procedure or surgery | Stratum 1 |
| Radiation TherapyExternal Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma. | Procedure or surgery | Stratum 2 |
Primary outcome
Local Tumor Control
Time frame: 12 months after the enrollment of the last therapeutic patient
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23245284Netson 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.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas E. Merchant, D.O., Ph.D. principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation Therapy in people with Central Nervous System Tumors and Brain Tumors, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Tumor Control (time frame: 12 months after the enrollment of the last therapeutic patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00187226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.