NeoplasmsNCT01255748
Registry Study for Radiation Therapy Outcomes
An observational study of Neoplasms, run by Proton Collaborative Group at 29 sites in United States.
Trial summary
The purpose of this research study is to collect and analyze information from patients being treated with various forms of radiation therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms
- What is being tested?
- Proton Therapy, Photon Therapy, SRS, Brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 50,000 participants
- Where
- 29 sitesUnited States
- Study dates
- Jun 2009to Jun 2039
- How long will I take part?
- 30 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Radiation Oncology patients
Who may be able to join
- Planned treatment with radiation therapy
- Ability to understand and sign IRB approved consent
Who cannot join
None listed.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
United States29 sites, 29 recruiting
- Recruiting
Emory Proton Therapy Center
Atlanta, Georgia, 30308
Leann Schilling, MPH, CCRP, 404-686-0286, leann.schilling@emory.edu
Mark McDonald, MD
- Recruiting
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
Caitlin Eggleston, 410-328-7586, caitlineggleston@umm.edu
Mark Mishra, MD
- Recruiting
Atrium Health Levine Cancer Proton & Advanced Radiation Center
Charlotte, North Carolina, 28204
Maggie Dzhanumova, 980-515-5300, margarita.dzhanumova@atriumhealth.org
Roshan Prabhu, MD
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45044
Christine Vollmer, MBA, 513-213-3203, mccordce@ucmail.uc.edu
Luke Pater, MD
- Recruiting
South Florida Proton Therapy Institute
Delray Beach, Florida, 33484
Salina Ramirez, 561-323-6360, sramirez@sfpti.com
James Snider, MD
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Sangeetha Moturi, 571-472-0343, sangeetha.moturi@inova.org
Gopal Bajaj, MD
- Recruiting
McLaren Proton Therapy Center
Flint, Michigan, 48532
Drita Nuculovic, 810-342-5674, drita.nuculovic@mclaren.org
Brian Yeh, MD
- Recruiting
Southwest Florida Proton Center
Fort Myers, Florida, 33967
Krisha Parikh, 239-516-0009, kparikh@swflproton.com
Shannon MacDonald, MD
- Recruiting
Tennessee Oncology Proton Center
Franklin, Tennessee, 37067
Erick Vides, 615-716-4736, evides@tnonc.com
James Gray, MD
- Recruiting
Hampton University Proton Therapy Institute
Hampton, Virginia, 23666
Donna Sternberg, RN, BSN, OCN, 757-251-6839, donna.sternberg@hamptonproton.org
Christopher Sinesi, MD
- Recruiting
Texas Center for Proton Therapy
Irving, Texas, 75063
Vanetta Zollicoffer, 469-513-5531, vanetta.zollicoffer@usoncology.com
Andrew Lee, MD
- Recruiting
Ackerman Cancer Center
Jacksonville, Florida, 32223
Mitchell Urmann, 904-880-5522, mitchellu@ackermancancer.com
Ryan Perkins, MD
- Recruiting
University of Kansas Proton Therapy Center
Kansas City, Kansas, 66160
Amanda Schroeder, 913-588-1617, aschroeder3@kumc.edu
Ronny Rotondo, MD
- Recruiting
Thompson Proton Center
Knoxville, Tennessee, 37909
Kristi Simcox, 865-331-4985, esimcox@covhlth.com
Ryan Grover, MD
- Recruiting
Proton Center of Arkansas
Little Rock, Arkansas, 72205
Monica Coleman, 501-686-8274, mmcoleman@uams.edu
Leslie Harrell, MD
- Recruiting
Dwoskin Proton Therapy Center
Miami, Florida, 33125
Felisa Flores, 305-243-4370, fflores2@med.miami.edu
Matthew Abramowitz, MD
- Recruiting
Miami Cancer Institute
Miami, Florida, 33176
Michael Chuong, MD, 786-596-2000, michaelchu@baptisthealth.net
Michael Chuong, MD
- Recruiting
New York Proton Center
New York, New York, 10035
Ryan Holder, 646-968-9055 ext. 387, rholder@nyproton.com
Charles Simone, MD, FACRO
- Recruiting
Oklahoma Proton Center
Oklahoma City, Oklahoma, 73142
Angela Beebe, 405-773-6708, angela.beebe@okcproton.com
John Chang, MD
- Recruiting
Orlando Health Cancer Institute
Orlando, Florida, 32806
Leila IP, BSN, RN, 321-843-3762, leila.ip@orlandohealth.com
Naren Ramakrishna, MD, Ph. D
- Recruiting
Kansas City Proton Institute
Overland Park, Kansas, 66207
Judy Searcy, 913-647-4173, jsearcy@kcuc.com
James Coster, MD
- Recruiting
OSF HealthCare Cancer Institute
Peoria, Illinois, 61603
Peyton Swearingen, 309-624-5013, peyton.o.swearingen@osfhealthcare.org
Timothy Smile, MD
- Recruiting
California Protons Cancer Therapy Center
San Diego, California, 92121
Alexandra Crawford, MPH, 858-549-7431, alexandra.crawford@californiaprotons.com
James Urbanic, MD
- Recruiting
Mayo Clinic
Scottsdale, Arizona, 85259-5499
Clinical Trials Office - All Mayo Clinic Locations, 855-776-0015 (toll free)
- Recruiting
University of Washington
Seattle, Washington, 98195-6043
Erica Peters, CCRC, CPM, 206-598-7188, etucker@uw.edu
Annemarie Shepherd, MD
- Recruiting
Willis-Knighton Cancer and Proton Therapy Center
Shreveport, Louisiana, 71103
Briana Barrow, CCRC, 318-212-8671, bbarrow@wkhs.com
Lane Rosen, MD
- Recruiting
ProCure Proton Therapy Center
Somerset, New Jersey, 08873
Heba Darwish, 732-357-2676, heba.darwish@nj.procure.com
Henry Tsai, MD
- Recruiting
Mercy David C. Pratt Cancer Center
St Louis, Missouri, 63141
Nancy Umbeck, 314-251-7066, nancy.umbeck@mercy.net
Amit Roy, MD
- Recruiting
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, 60555
Don Smith, MS, CCRC, 630-933-7820, donald.smith3@nm.org
Arpi Thukral, MD
About this study
Official title: Evaluation Tracking Project: A Prospective Chart Review of Patients Treated With Radiation Therapy
The purpose of this research study is to collect and analyze information from patients being treated with various forms of radiation therapy.
- Conditions
- Neoplasms
- Being tested
- Proton Therapy, Photon Therapy, SRS, Brachytherapy
- Keywords
- cancer, proton, radiation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Therapy, Photon Therapy, SRS, BrachytherapyRadiation
Outcomes Tracking
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Radiation Therapy | Includes 16 different arms to capture patient data by disease site Receives: Radiation: Proton Therapy, Photon Therapy, SRS, Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define outcomes for patients treated at participating institutions
Measured: PRN
Secondary outcomes (2)
Determine strategies necessary to improve patients outcome and decrease toxicities related to treatments and procedures
Measured: Annually PRN
Improve patient care by an adequate understanding of the results and patient population at participating institutions
Measured: Reviewed Annually PRN
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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
- 50,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Proton Collaborative Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Carlos Vargas, MD, Study chair, Proton Collaborative Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255748
- Sponsor's protocol ID
- REG001-09
- Status last verified
- Sep 2026
- First submitted
- 6 Dec 2010
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee HJ Jr, Macomber MW, Spraker MB, Bowen SR, Hippe DS, Fung A, Russell KJ, Laramore GE, Rengan R, Liao J, Apisarnthanarax S, Zeng J. Early toxicity and patient reported quality-of-life in patients receiving proton therapy for localized prostate cancer: a single institutional review of prospectively recorded outcomes. Radiat Oncol. 2018 Sep 17;13(1):179. doi: 10.1186/s13014-018-1127-6.
PubMed 30223877
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Tracking Project: A Prospective Chart Review of Patients Treated With Radiation Therapy
- ClinicalTrials.gov ID
- NCT01255748
- Acronym / sponsor ID
- REG001-09
- Conditions
- Neoplasms
- Keywords
- cancer, proton, radiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Proton Collaborative GroupResearch network
- Study start
- Jun 2009
- Primary completion
- Jun 2039 (estimated)
- First posted
- 7 Dec 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.
The purpose of this research study is to collect and analyze information from patients being treated with various forms of radiation therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Radiation Therapy | – | Radiation: Proton Therapy, Photon Therapy, SRS, BrachytherapyIncludes 16 different arms to capture patient data by disease site |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Radiation Oncology patients
Key inclusion criteria (2 listed)
- Planned treatment with radiation therapy
- Ability to understand and sign IRB approved consent
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 |
|---|---|---|
| Proton Therapy, Photon Therapy, SRS, BrachytherapyOutcomes Tracking | Radiation | Treatment with Radiation Therapy |
Primary outcome
Define outcomes for patients treated at participating institutions
Time frame: PRN
2 secondary outcomes
Determine strategies necessary to improve patients outcome and decrease toxicities related to treatments and procedures
Time frame: Annually PRN
Improve patient care by an adequate understanding of the results and patient population at participating institutions
Time frame: Reviewed Annually PRN
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 29 Sep 2026.
- Derived from this study: PubMed 30223877Lee HJ Jr, Macomber MW, Spraker MB, Bowen SR, Hippe DS, Fung A, Russell KJ, Laramore GE, Rengan R, Liao J, Apisarnthanarax S, Zeng J. Early toxicity and patient reported quality-of-life in patients receiving proton therapy for localized prostate cancer: a single institutional review of prospectively recorded outcomes. Radiat Oncol. 2018 Sep 17;13(1):179. doi: 10.1186/s13014-018-1127-6.
- Sponsor's websiteLink 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.
California Protons Cancer Therapy Center
San Diego, United States
Carlos Vargas, MD study chair
Proton Collaborative Group
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Proton Collaborative Group at 29 sites 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 2 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define outcomes for patients treated at participating institutions (time frame: PRN). 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 NCT01255748, 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 29 Sep 2026.