Grid Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.

NCT ID: NCT04549246

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2024-06-01

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.

Conditions

Radiation Therapy Complication; Tumor Neck; Tumor Abdomen

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Dawn M. Owen, M.D., Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn Owen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2022-105

Identifier Type: REGISTRY

Identifier Source: secondary_id

ROR1903

Identifier Type: OTHER

Identifier Source: secondary_id

19-012801

Identifier Type: OTHER

Identifier Source: secondary_id

24-005944

Identifier Type: OTHER

Identifier Source: secondary_id

ROR1903

Identifier Type: -

Identifier Source: org_study_id