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Proton Beam Therapy

Radiation Therapy + Chemotherapy + Boost Radiation for Oral Cancer

Phase 2
Waitlist Available
Led By Michelle Mierzwa, M.D.
Research Sponsored by University of Michigan Rogel Cancer Center
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 years post treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve treatment for patients with hard-to-treat head and neck cancer by using MRI to find and give extra radiation to the toughest parts of their tumors.

Eligible Conditions
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Free Survival (DSF) time
Secondary study objectives
Correlation coefficient between continuous dose and perfusion summary measures
Local-regional control rate
Number of patients with adverse events

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
Active Control
Group I: Boost ArmExperimental Treatment4 Interventions
Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)
Group II: Control ArmActive Control3 Interventions
Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Carboplatin
2014
Completed Phase 3
~6120
IMRT (Intensity-Modulated Radiation Therapy)
2014
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,812 Previous Clinical Trials
8,161,365 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
24,259 Total Patients Enrolled
Michelle Mierzwa, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center
3 Previous Clinical Trials
123 Total Patients Enrolled

Media Library

IMRT (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02031250 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Control Arm, Boost Arm
Squamous Cell Carcinoma Clinical Trial 2023: IMRT Highlights & Side Effects. Trial Name: NCT02031250 — Phase 2
IMRT (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02031250 — Phase 2
~9 spots leftby Nov 2025
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