Trial Information

Pediatric Proton Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Proton Radiation Therapy

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 The Quality Assurance Review Center
(QARC). QARC is a program affiliated with teh UMass Medical School that provides
diagnostic imaging data management services.