- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04549246
Grid Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities. (ROR1903)
March 12, 2024 updated by: Dawn M. Owen, M.D., Ph.D., Mayo Clinic
Spatially Fractionated Radiation (Grid) Therapy for Tumors of the Head & Neck, Thorax, Abdomen, Pelvis, and Extremities
This study is an observational registry study evaluating the clinical outcomes of grid therapy.
Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study.
Once consent has been obtained, baseline adverse event and QOL data will be collected and subjects will undergo grid therapy and follow-up at 2-4 weeks (for toxicity), and 3-6 months (for toxicities and radiographic control) then per clinical discretion up to 1 year.
Patients will be evaluated according to the physician's standard practice and discretion.
Patient data will be drawn from the patients' medical records and reported by means of a web-based electronic data collection (EDC) system.
Patients will be considered "on study" until 60 months of observation has occurred, withdrawal of consent, lost to follow-up, or study closure.
See below for the clinical visit flowchart for data collected at baseline and standard clinic visits.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tammy Lenz
- Phone Number: 507-293-0614
- Email: lenz.tamara@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Dawn Owen, M.D., Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with tumors of the head, neck, thorax, abdomen, pelvis and extremities.
Description
Inclusion Criteria:
- Patients with tumors of the head and neck, thorax, abdomen, pelvis, and extremities.
- Age ≥ 18 years.
- Histological confirmation of oncologic diagnosis.
- Completed oncologic imaging (per discretion of treating physician)
- ECOG Performance Status 0-3
- Ability to complete questionnaire(s) by themselves or with assistance.
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
- Provide informed written consent.
Exclusion Criteria:
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local/radiographic control rate
Time Frame: 3-6 months
|
Assessed according to Response Evaluation Criteria In Solid Tumors (RECIST), a standard system to measure how cancer responds to different treatments, including chemotherapy, immunotherapy, and radiation therapy.
The local/radiographic control rate will be estimated overall and by palliative/definitive patient status in patients treated with grid therapy.
|
3-6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence rate
Time Frame: through study completion, approximately 5 years
|
Number of patients to have tumor recurrence after grid therapy
|
through study completion, approximately 5 years
|
Planning and delivery of grid therapy.
Time Frame: 5 years
|
Total amount of time taken for planning and delivery of grid therapy
|
5 years
|
To describe the adverse event profile (acute and late) of grid therapy by assessment of grade 3 or higher adverse events
Time Frame: through study completion, approximately 5 years
|
Assessed by the number of grade 3 or higher adverse events (acute and late) that occur after grid therapy.
Adverse events will be defined based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria.
|
through study completion, approximately 5 years
|
Overall survival after grid therapy
Time Frame: through study completion, approximately 5 years
|
Overall survival is defined as the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.
|
through study completion, approximately 5 years
|
Local/regional progression after grid therapy
Time Frame: through study completion, approximately 5 years
|
Assessed by the number of patients to have local and/or regional progression after grid therapy.
Local progression is defined as cancer recurring in the same place as the original cancer or very close to it.
Regional progression is defined as cancer/tumor that has grown or spread into lymph nodes or tissues near the original cancer.
|
through study completion, approximately 5 years
|
Distant disease control
Time Frame: through study completion, approximately 5 years
|
Distant disease control is defined as cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.
|
through study completion, approximately 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dawn Owen, M.D., Ph.D., Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 18, 2020
Primary Completion (Estimated)
June 18, 2025
Study Completion (Estimated)
June 18, 2025
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
September 8, 2020
First Posted (Actual)
September 16, 2020
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROR1903 (Other Identifier: Mayo Clinic Radiation Oncology)
- 19-012801 (Other Identifier: Mayo Clinic Institutional Review Board)
- NCI-2022-105 (Registry Identifier: CTRP (Clinical Trials Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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