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GRID Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities. (ROR1903)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04549246
Recruitment Status : Active, not recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Daniel J. Ma, M.D., Mayo Clinic

Brief 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. 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.

Condition or disease Intervention/treatment
Radiation Therapy Complication Tumor Neck Tumor Abdomen Radiation: Spatially Fractionated Radiation (GRID) Therapy

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ROR1903: Spatially Fractionated Radiation (Grid) Therapy for Tumors of the Head & Neck, Thorax, Abdomen, Pelvis, and Extremities
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : June 18, 2025
Estimated Study Completion Date : June 18, 2025

Intervention Details:
  • Radiation: Spatially Fractionated Radiation (GRID) Therapy
    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.


Primary Outcome Measures :
  1. To describe the local/radiographic control rate (per RECIST) in patients treated with GRID therapy. [ Time Frame: 3-6 months ]

Secondary Outcome Measures :
  1. To describe the adverse event profile (acute and late) of grid therapy by assessment of grade 3 or higher adverse events NCI-CTCAE v. 5 criteria. [ Time Frame: through study completion, approximately 5 years ]
  2. Overall survival [ Time Frame: through study completion, approximately 5 years ]
    Patient survival rate after grid therapy

  3. Local/regional progression [ Time Frame: through study completion, approximately 5 years ]
    Patient progression after grid therapy

  4. Recurrence rate [ Time Frame: through study completion, approximately 5 years ]
    Number of patients to have tumor recurrence after grid therapy

  5. Distant disease control [ Time Frame: through study completion, approximately 5 years ]
  6. Planning and delivery of grid therapy. [ Time Frame: 5 years ]
    Total amount of time taken for planning and delivery of grid therapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with tumors of the head, neck, thorax, abdomen, pelvis and extremities.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549246


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Daniel Ma, MD Mayo Clinic Radiation Oncology
Additional Information:
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Responsible Party: Daniel J. Ma, M.D., Associate Professor of Radiation Oncology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04549246    
Other Study ID Numbers: 19-012801
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms