Prospective Patient Registry for Radiation Oncology Techniques and Quality (GCC 1490)

• ClinicalTrials.gov Identifier: NCT02368106
• Recruitment Status: Withdrawn
• First Posted: February 20, 2015
• Last Update Posted: September 12, 2019
• Sponsor: University of Maryland, Baltimore
• Information provided by (Responsible Party): Department of Radiation Oncology, University of Maryland, Baltimore

Tracking Information

• First Submitted Date: January 20, 2015
• First Posted Date: February 20, 2015
• Last Update Posted Date: September 12, 2019
• Estimated Study Start Date: February 2018
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 13, 2015)

Numbers of patients experiencing toxicities/adverse events both during and at follow-up after radiation therapy with any of 11 therapeutic modalities. [ Time Frame: 5 years ]

Records will be assessed to identify per-patient numbers and grades of toxicities and adverse events resulting from radiation treatment for oncologic conditions as graded by treating physicians according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) during the period of radiation treatment and at each regularly scheduled clinical follow-up appointment, for each of the 11 therapeutic modalities listed as interventions.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 13, 2015)

• Numbers of patients with different initial diagnoses associated with short- and long-term toxicities with specific radiation treatments. [ Time Frame: 5 years ]
  Records will be assessed to identify numbers of patients with specific initial diagnoses (from approximately 100 International Statistical Classification of Diseases and Related Health Problems [ICD 9] malignant neoplasm diagnoses) who experience short- and long-term toxicities after any of the 11 therapeutic modalities listed as interventions.
• Numbers of men and women who experience short- and long-term toxicities after specific radiation treatments. [ Time Frame: 5 years ]
  Records will be assessed to identify numbers of men and women who experience CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.
• Age differences in short- and long-term toxicities associated with specific radiation treatment modalities. [ Time Frame: 5 years ]
  Records will be assessed to identify numbers of men and women between the ages of 18-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, and ≥90 years who experience CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.
• Patient income differences in short- and long-term toxicities associated with specific radiation treatment modalities. [ Time Frame: 5 years ]
  Records will be assessed for income (by patient home zip code per U.S. Internal Revenue statistics available at http://www.irs.gov/uac/SOI-Tax-Stats-Individual-Income-Tax-Statistics-ZIP-Code-Data-(SOI)) to identify income level differences and per-patient numbers/ types of CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prospective Patient Registry for Radiation Oncology Techniques and Quality
• Official Title: Patient Registry for Prospective Research on Evolving Radiation Oncology Techniques and Quality
• Brief Summary: This study will create a patient data registry to collect and analyze information on technology usage and outcomes among patients receiving a broad range of relatively new radiation treatments that have become standards of care in our practice. Review of this information will serve as a basis for development of better patient management plans, to inform decisions about acquisition of new technologies, to provide information about quality in our care delivery, and to create a database that will securely warehouse ongoing information about what treatments the patients we serve need most and the challenges they face in the treatment process. The information gathered is likely to not only improve our services at the University of Maryland and its community sites but to advance medical science and enhance the quality of care for cancer patients.

Detailed Description

The purpose of this study is to create a robust and long-term patient data registry containing limited demographic, diagnostic, treatment, and follow-up data on patients at the study sites undergoing one or more of the following radiation treatments/technologies:

Brachytherapy, including High-Dose-Rate and Low-Dose-Rate Techniques/ GammaPod Therapy/ GRID Treatment/ Image-Guided Radiation Therapy/ Intensity-Modulated Radiation Therapy and Intensity-Modulated Arc Therapy/ MammoSite and SAVI Applicator/ Photodynamic Therapy/ Proton Therapy/ SIR Spheres and Radiolabeled Microsphere Therapy/ Stereotactic Radiosurgery and Stereotactic Body Radiotherapy/ Thermal Therapy (Hyperthermia)

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Primary care clinic

Condition

• Solid Tumors
• Cancer

Intervention

Radiation: Radiation Therapy

targeted radiation treatment

Study Groups/Cohorts

Radiation Therapy

Participants receiving one of the 11 listed therapy modalities.

Intervention: Radiation: Radiation Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: March 12, 2018): 0
• Original Estimated Enrollment (submitted: February 13, 2015): 5000
• Estimated Study Completion Date: December 2030
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients who are 18 years old or older and scheduled to undergo any of the listed radiation treatment technologies at the University of Maryland Medical Center or one of its community sites as included in this protocol provided s/he consents to participate.

Exclusion Criteria:

• Patients who are incarcerated or in legal custody are not eligible for this study.
• Patients who are younger than 18 years, are cognitively impaired, or are otherwise unable to provide informed consent.
• Patients who are pregnant

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02368106
• Other Study ID Numbers: HP-00060494
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Department of Radiation Oncology, University of Maryland, Baltimore
• Study Sponsor: University of Maryland, Baltimore
• Collaborators: Not Provided

Investigators

• Principal Investigator: William Regine, MD; UMMC MSGCC Department of Radiation Oncology

• PRS Account: University of Maryland, Baltimore
• Verification Date: September 2019