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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 baseline, at last day of radiotherapy (day 3), within 2 weeks after completion of radiotherapy (day 14), 30 days, 90 days, 180 days, and 360 days
Awards & highlights
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~baseline, at last day of radiotherapy (day 3), within 2 weeks after completion of radiotherapy (day 14), 30 days, 90 days, 180 days, and 360 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at last day of radiotherapy (day 3), within 2 weeks after completion of radiotherapy (day 14), 30 days, 90 days, 180 days, and 360 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of treatment-related acute toxicity
Rate of treatment-related late toxicity
Secondary study objectives
Change in PRO-CTCAE (General Inventory and Disease Specific Inventory Assessment)
Change in PROMIS Global Health

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,995 Previous Clinical Trials
2,296,873 Total Patients Enrolled
Anthony Apicelli, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
19 Total Patients Enrolled

Media Library

Proton GRID Radiotherapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05831579 — N/A
Solid Tumors Research Study Groups: Cohort A: Reirradiation of Treatment Fields, Cohort B: De Novo Radiation Treatment Fields
Solid Tumors Clinical Trial 2023: Proton GRID Radiotherapy Highlights & Side Effects. Trial Name: NCT05831579 — N/A
Proton GRID Radiotherapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05831579 — N/A
~9 spots leftby May 2026
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