Radiation Therapy ComplicationNCT04549246
Grid Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.
An observational study of Radiation Therapy Complication and Tumor Neck, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Therapy Complication, Tumor Neck, Tumor Abdomen
- What is being tested?
- Spatially Fractionated Radiation (GRID) Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2020to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tumors of the head, neck, thorax, abdomen, pelvis and extremities.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Radiation Therapy Complication, Tumor Neck, Tumor Abdomen
- Being tested
- Spatially Fractionated Radiation (GRID) Therapy
- Medical subject headings
- Head and Neck Neoplasms, Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatially Fractionated Radiation (GRID) TherapyRadiation
Grid therapy allows for high doses of radiation to be delivered over several spatially distinct, small regions. This permits regions of very high dose to a large tumor away from critical structures, which could be beneficial in both palliative and definitive treatments. Additionally, allowing for high doses to be delivered could pose a benefit for radioresistant histologies.
What is being measured
The primary outcome is the main question the study is designed to answer.
Local/radiographic control rate
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.
Measured: 3-6 months
Secondary outcomes (6)
To describe the adverse event profile (acute and late) of grid therapy by assessment of grade 3 or higher adverse events
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.
Measured: through study completion, approximately 5 years
Overall survival after grid therapy
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.
Measured: through study completion, approximately 5 years
Local/regional progression after grid therapy
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.
Measured: through study completion, approximately 5 years
Recurrence rate
Number of patients to have tumor recurrence after grid therapy
Measured: through study completion, approximately 5 years
Distant disease control
Distant disease control is defined as cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.
Measured: through study completion, approximately 5 years
Planning and delivery of grid therapy.
Total amount of time taken for planning and delivery of grid therapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start18 Jun 2020
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation Therapy ComplicationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn M. Owen, M.D., Ph.D., Mayo Clinic
- Investigators
- Dawn Owen, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549246
- Sponsor's protocol ID
- ROR1903
- Other IDs
- NCI-2022-105, ROR1903, 19-012801, 24-005944
- Status last verified
- Jul 2024
- First submitted
- 13 Aug 2020
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatially Fractionated Radiation (Grid) Therapy for Tumors of the Head & Neck, Thorax, Abdomen, Pelvis, and Extremities
- ClinicalTrials.gov ID
- NCT04549246
- Acronym / sponsor ID
- ROR1903
- Conditions
- Radiation Therapy Complication, Tumor Neck, Tumor Abdomen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 16 Sep 2020 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tumors of the head, neck, thorax, abdomen, pelvis and extremities.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- 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.
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 |
|---|---|---|
| Spatially Fractionated Radiation (GRID) TherapyGrid therapy allows for high doses of radiation to be delivered over several spatially distinct, small regions. This permits regions of very high dose to a large tumor away from critical structures, which could be beneficial in both palliative and definitive treatments. Additionally, allowing for high doses to be delivered could pose a benefit for radioresistant histologies. | Radiation | – |
Primary outcome
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.
6 secondary outcomes
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
Overall survival after grid therapy
Time frame: through study completion, approximately 5 years
Local/regional progression after grid therapy
Time frame: through study completion, approximately 5 years
Recurrence rate
Time frame: through study completion, approximately 5 years
Distant disease control
Time frame: through study completion, approximately 5 years
Planning and delivery of grid therapy.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dawn Owen, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Therapy Complication and Tumor Neck, run by Mayo Clinic at 1 site 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local/radiographic control rate (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.