Clinical trial NCT01696721: Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy
Official title: Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Patients Treated With Radiation Therapy
Keywords: Proton Therapy
Pediatrics
Radiation Oncology
Photon Therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 5000
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients age \<22 treated with radiation therapy

Brief summary: In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better results in treating patients with cancer, both because there is better control of where in the body the radiation is directed and because it is associated with less severe long term side effects. However, there is limited published data demonstrating these results. The goal of the Proton and Photon Consortium Registry (PPCR) is to enroll children treated with radiation in order to describe the population that currently receives radiation and better compare the short-term and long-term benefits of different types of radiotherapy. The data collected from this study will help facilitate research on radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data that many centers that deliver radiation therapy already collect in routine operations.

Detailed description: Once you are enrolled in the study, you will receive treatment, evaluations and follow up care for your type of cancer as determined by your treating physician according to clinical judgment and standard of care for your clinic. All treatments that you receive will be recorded, including all surgeries and chemotherapy given before or after PBRT. Treatment outcomes, like how you respond to treatment, side effects, and progression of your cancer will be collected as the information becomes available. A study coordinator or research nurse at your clinic will perform a chart review annually to update your status in the database. The study doctor will request any new data within the past year from you or your doctor.

We will be collecting the following data for the Registry:

At Screening: The following data will be collected from the time of diagnosis and initial staging:

* Patient demographics, date of birth, gender, race, zip code and insurance status
* Date of diagnosis
* Histologic or clinical diagnosis and staging relevant to diagnosis
* Imaging studies obtained and tumor measurements
* Lab evaluations which include routine blood tests, hormone levels, and any relevant lab results needed to assess you and baseline and follow-up visits
* Referring physician contact information

Treatment Data Collection: The following data regarding treatment will be collected:

* Treatments received before radiation therapy, including surgery, chemotherapy, dates and numbers of cycles, results of chemotherapy if available
* Dates and doses of radiation treatment
* Side effects observed
* Any treatments you received at the same time as proton radiation therapy

Follow-up Data Collection: The following data will be collected either as it comes in or annually following completion of your radiation therapy treatment:

* Disease and survival status
* Hospitalization, surgeries or other procedures
* New diagnoses of medical conditions
* Any lab results, including x-rays
* Medications you are taking
* Late side effects such as hearing loss, hormonal issues, any cardiac issues
* Development of any new types of cancers
* Dates of treatment after radiation therapy
* If you discontinued radiation therapy
* Laboratory/physician/dental or psychological evaluations
* Use of special services in school (IEP, FM hearing system, one on one tutor, special education) We would like to keep track of your medical condition for the rest of your life. We would like to do this by contacting you or your doctor once a year to see how you are doing. Keeping in touch with you and checking on your condition helps determine the long-term outcomes of individuals treated with proton beam radiation therapy.

In addition to research personnel at MGH, there are others that may have access to the data collected. This includes:

* Other research doctors and medical centers participating in this research, if applicable
* Outside individuals or entities that have a need to access this information to perform functions relating to the conduct of this research. For instance copies of your imaging studies and treatment plan will be stored at MIMcloud. MIMcloud is a service offered through MIM Software Inc, a privately held company, that provides diagnostic imaging data management services.

Eligibility criteria: Eligibility Criteria:

1. Patients treated with radiation therapy at one of the participating centers
2. Age \< 22 at time of treatment start.
3. Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in the PPCR.
4. Patients may be enrolled regardless of other current local or systemic treatments or disease extent.
5. Patients may be enrolled on the PPCR concurrently with another study or clinical trial.

Primary outcomes:
measure: Establish Registry
timeFrame: 2 years
Secondary outcomes:
measure: Describe patterns of care
timeFrame: 2 years
measure: Describe patterns of follow-up
timeFrame: 2 years
measure: Describe acute and late effects
timeFrame: 2 years
measure: Establish a cohort of photon-treated patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Health Proton Therapy Institute
state: Florida
city: Warrenville
country: United States
facility: Northwestern Medicine Chicago Proton Center
state: Illinois
city: Baltimore
country: United States
facility: Maryland Proton Treatment Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Somerset
country: United States
facility: ProCure Proton Therapy Center- New Jersey
state: New Jersey
city: Liberty Township
country: United States
facility: Cincinnati Children's Proton Therapy Center
state: Ohio
city: Oklahoma City
country: United States
facility: ProCure Proton Therapy Center- Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania - Roberts Proton Therapy Center
state: Pennsylvania
city: Knoxville
country: United States
facility: Provision CARES Proton Therapy Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: Texas Center for Proton Therapy
state: Texas
city: Seattle
country: United States
facility: University of Washington- Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Massachusetts General Hospital
name: Torunn I Yock, MD
role: PRINCIPAL_INVESTIGATOR
References: