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

Completed

• Conditions: Tumor Neck; Radiation Therapy Complication; Tumor Abdomen

• Registration Number: NCT04549246
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-18
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Local/radiographic control rate	3-6 months	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.

Secondary Outcome Measures

Name	Time	Method
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	Assessed by the number of grade 3 or higher adverse events (acute and late) that occur after grid therapy. Adverse events will be defined based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria.
Planning and delivery of grid therapy.	5 years	Total amount of time taken for planning and delivery of grid therapy
Overall survival after grid therapy	through study completion, approximately 5 years	Overall survival is defined as the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.
Local/regional progression after grid therapy	through study completion, approximately 5 years	Assessed by the number of patients to have local and/or regional progression after grid therapy. Local progression is defined as cancer recurring in the same place as the original cancer or very close to it. Regional progression is defined as cancer/tumor that has grown or spread into lymph nodes or tissues near the original cancer.
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	Distant disease control is defined as cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States