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

NCT04549246 | Completed

• 4 other identifiers: ROR1903NCI-2022-10519-01280124-005944
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  through study completion, approximately 5 years

• Overall survival after grid therapy

  through study completion, approximately 5 years

• Local/regional progression after grid therapy

  through study completion, approximately 5 years

• Recurrence rate

  through study completion, approximately 5 years

• Distant disease control

  through study completion, approximately 5 years

Interventions

Spatially Fractionated Radiation (GRID) Therapy RADIATION

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with tumors of the head, neck, thorax, abdomen, pelvis and extremities.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Head and Neck Neoplasms; Abdominal Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Dawn Owen, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: September 16, 2020
• Study Start: June 18, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)