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Proton Beam Therapy
Proton Radiotherapy for Palliative Cancer Care
N/A
Recruiting
Led By Anthony Apicelli, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial will use a form of radiation therapy to treat tumors that need palliative care. It aims to be effective, immunogenic, and low in toxicity.
Who is the study for?
This trial is for adults with confirmed cancer who need palliative radiation for large tumors or previously irradiated lesions. Participants must agree to use contraception and have an ECOG performance status ≤ 3. Excluded are those needing urgent surgery, pregnant women, patients on certain cancer therapies overlapping with the trial, and HIV-positive individuals with low CD4+ counts or recent opportunistic infections.Check my eligibility
What is being tested?
The study tests Proton GRID Radiotherapy as a three-fraction palliative treatment for cancerous tumors. It aims to see if this method, which creates high-dose areas within the tumor while sparing surrounding tissue, is safe and effective compared to traditional radiotherapy.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of radiotherapy include skin reactions at the treatment site, fatigue, nausea, and potential damage to nearby organs depending on the tumor's location.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of treatment-related acute toxicity
Rate of treatment-related late toxicity
Secondary outcome measures
Change in PRO-CTCAE assessment
Change in PROMIS Global Health
Rate of target lesion local control
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: De Novo Radiation Treatment FieldsExperimental Treatment1 Intervention
Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.
Group II: Cohort A: Reirradiation of Treatment FieldsExperimental Treatment1 Intervention
Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,790 Total Patients Enrolled
Anthony Apicelli, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
19 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any cancer treatments that would interfere with proton GRID therapy.I am in a group of 10 patients with previously irradiated lesions.My tumor requires immediate surgery.I had radiation for a cancer lesion less than 1 cm deep.I am planning to have radiotherapy for a large, inoperable cancer lesion.I am in a group of 10 patients with lesions that have never been treated with radiation.I am capable of only limited self-care, confined to a bed or chair more than 50% of waking hours.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Reirradiation of Treatment Fields
- Group 2: Cohort B: De Novo Radiation Treatment Fields
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being welcomed into this research endeavor?
"This trial, which was originally listed on June 30th 2023 and last updated April 25th 2023 is not presently recruiting any participants. However, there are 744 other clinical trials actively searching for eligible patients at this moment in time."
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