Clinical trial NCT04549246: Grid Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.
Official title: Spatially Fractionated Radiation (Grid) Therapy for Tumors of the Head & Neck, Thorax, Abdomen, Pelvis, and Extremities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Therapy Complication
Tumor Neck
Tumor Abdomen
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with tumors of the head, neck, thorax, abdomen, pelvis and extremities.

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.


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.

Primary outcomes:
measure: Local/radiographic control rate
timeFrame: 3-6 months
Secondary outcomes:
measure: To describe the adverse event profile (acute and late) of grid therapy by assessment of grade 3 or higher adverse events
timeFrame: through study completion, approximately 5 years
measure: Overall survival after grid therapy
timeFrame: through study completion, approximately 5 years
measure: Local/regional progression after grid therapy
timeFrame: through study completion, approximately 5 years
measure: Recurrence rate
timeFrame: through study completion, approximately 5 years
measure: Distant disease control
timeFrame: through study completion, approximately 5 years
measure: Planning and delivery of grid therapy.
timeFrame: 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dawn Owen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: