Brain TumorsNCT01115777
Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-central Nervous System (Non-CNS) Malignancies
An observational study of Brain Tumors and Non-CNS Malignancies, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In recent years, remarkable advances in medical oncology, surgery, and radiology have allowed for increasing cure rates for childhood malignancies. This success has led to an emerging understanding of the kinds of effects that treatments can have on the pediatric population and how such effects can influence pediatric… Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Brain Tumors, Non-CNS Malignancies
- What is being tested?
- Quality of Life surveys completed at specified timepoints
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients coming to MGH for radiation therapy with curative intent.
Who may be able to join
- Any patient being treated with radiation therapy with curative intent
- Patients between the ages of 2 and 25
- Patients who speak either English or Spanish
- Patients who agree to fill out the questionnaire
Who cannot join
- Patients younger than 2 years of age or over 25
- Patients receiving treatment with palliative intent
- Patients who do not wish to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-CNS Malignancies
In recent years, remarkable advances in medical oncology, surgery, and radiology have allowed for increasing cure rates for childhood malignancies. This success has led to an emerging understanding of the kinds of effects that treatments can have on the pediatric population and how such effects can influence pediatric cancer survivor's functioning and quality of life. It has become tremendously important to assess the long-term complications due to therapy in this growing sector of survivors and to tailor our treatments so as to minimize these late effects.
The Investigators at MGH are committed to improving the delivery of radiotherapy to our patients and improving the outcome for these patients. MGH has an on-site cyclotron for proton radiotherapy in order to provide the most advanced care for patients in need. Proton therapy possesses a clinical advantage over standard photon therapy in that its optimal dose distribution delivers the bulk of radiation to the tumor site. This method spares the greatest volume of normal tissue, resulting in decreased short-term and long-term morbidity.
Read more
Through open pediatric protocols for patients treated with proton radiotherapy, the investigators aim to define and report the acute and late effects associated with treatment.
The investigators also treat a number of patients off-protocol with both proton and photon radiotherapy, and are interested in reporting these patients' QOL outcomes in conjunction with other clinical data that may be pertinent to the site of tumor treatment. This research is significant in that it will allow us to delineate the positive and negative effects of radiation treatment on patients' QOL, highlighting points of success and exposing areas that are in need of improvement. Such knowledge will be used to improve the experience of pediatric cancer survivors in the future.
The aims of this study are: 1) to prospectively collect and report the QOL outcomes in patients treated with radiotherapy and 2) to correlate the QOL data with pertinent clinical information.
Read the detailed description
You will be asked to complete a series of questionnaires during your treatment and annually thereafter.
- Conditions
- Brain Tumors, Non-CNS Malignancies
- Being tested
- Quality of Life surveys completed at specified timepoints
- Keywords
- Pediatric patients, treated with, radiation therapy, for brain tumors, and non-CNS malignancies
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life surveys completed at specified timepointsOther
Quality of Life surveys (no treatment)
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients treated with radiotherapy | Not described Receives: Other: Quality of Life surveys completed at specified timepoints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Quality of Life
Longitudinal description of quality of life outcomes in patients treated with radiation therapy
Measured: 10 years
Secondary outcomes (1)
Correlation of QOL data with clinical information
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startSep 2005
- Primary completionJun 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torunn Yock, MD, Massachusetts General Hospital
- Investigators
- Torunn Yock, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115777
- Sponsor's protocol ID
- 2005P001629
- Status last verified
- May 2026
- First submitted
- 30 Apr 2010
- Last updated
- 13 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-CNS Malignancies
- ClinicalTrials.gov ID
- NCT01115777
- Acronym / sponsor ID
- 2005P001629
- Conditions
- Brain Tumors, Non-CNS Malignancies
- Keywords
- Pediatric patients, treated with, radiation therapy, for brain tumors, and non-CNS malignancies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, remarkable advances in medical oncology, surgery, and radiology have allowed for increasing cure rates for childhood malignancies. This success has led to an emerging understanding of the kinds of effects that treatments can have on the pediatric population and how such effects can influence pediatric cancer survivor's functioning and quality of life. It has become tremendously important to assess the long-term complications due to therapy in this growing sector of survivors and to tailor our treatments so as to minimize these late effects.
The Investigators at MGH are committed to improving the delivery of radiotherapy to our patients and improving the outcome for these patients. MGH has an on-site cyclotron for proton radiotherapy in order to provide the most advanced care for patients in need. Proton therapy possesses a clinical advantage over standard photon therapy in that its optimal dose distribution delivers the bulk of radiation to the tumor site. This method spares the greatest volume of normal tissue, resulting in decreased short-term and long-term morbidity.
Through open pediatric protocols for patients treated with proton radiotherapy, the investigators aim to define and report the acute and late effects associated with treatment.
The investigators also treat a number of patients off-protocol with both proton and photon radiotherapy, and are interested in reporting these patients' QOL outcomes in conjunction with other clinical data that may be pertinent to the site of tumor treatment. This research is significant in that it will allow us to delineate the positive and negative effects of radiation treatment on patients' QOL, highlighting points of success and exposing areas that are in need of improvement. Such knowledge will be used to improve the experience of pediatric cancer survivors in the future.
The aims of this study are: 1) to prospectively collect and report the QOL outcomes in patients treated with radiotherapy and 2) to correlate the QOL data with pertinent clinical information.
Detailed description
You will be asked to complete a series of questionnaires during your treatment and annually thereafter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients treated with radiotherapy | – | Other: Quality of Life surveys completed at specified timepoints |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients coming to MGH for radiation therapy with curative intent.
Key inclusion criteria (4 listed)
- Any patient being treated with radiation therapy with curative intent
- Patients between the ages of 2 and 25
- Patients who speak either English or Spanish
- Patients who agree to fill out the questionnaire
Key exclusion criteria (3 listed)
- Patients younger than 2 years of age or over 25
- Patients receiving treatment with palliative intent
- Patients who do not wish to participate
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 |
|---|---|---|
| Quality of Life surveys completed at specified timepointsQuality of Life surveys (no treatment) | Other | Pediatric patients treated with radiotherapy |
Primary outcome
Assessment of Quality of Life
Time frame: 10 years
Longitudinal description of quality of life outcomes in patients treated with radiation therapy
1 secondary outcome
Correlation of QOL data with clinical information
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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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.
Torunn Yock, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumors and Non-CNS Malignancies, run by Massachusetts General 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Assessment of Quality of Life (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026.