ROR1903: GRID Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.
Study Details
Study Description
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 | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- To describe the local/radiographic control rate (per RECIST) in patients treated with GRID therapy. [3-6 months]
Secondary Outcome Measures
- 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. [through study completion, approximately 5 years]
- Overall survival [through study completion, approximately 5 years]
Patient survival rate after grid therapy
- Local/regional progression [through study completion, approximately 5 years]
Patient progression after grid therapy
- Recurrence rate [through study completion, approximately 5 years]
Number of patients to have tumor recurrence after grid therapy
- Distant disease control [through study completion, approximately 5 years]
- Planning and delivery of grid therapy. [5 years]
Total amount of time taken for planning and delivery of grid therapy
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with tumors of the head and neck, thorax, abdomen, pelvis, and extremities.
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Age ≥ 18 years.
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Histological confirmation of oncologic diagnosis.
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Completed oncologic imaging (per discretion of treating physician)
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ECOG Performance Status 0-3
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Ability to complete questionnaire(s) by themselves or with assistance.
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Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
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Provide informed written consent.
Exclusion Criteria:
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Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
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Pregnant women
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Nursing women
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Women of childbearing potential who are unwilling to employ adequate contraception
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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.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Daniel Ma, MD, Mayo Clinic Radiation Oncology
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 19-012801