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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years post treatment
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
2,826 Previous Clinical Trials
8,166,450 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
21,109 Total Patients Enrolled
Michelle Mierzwa, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center
3 Previous Clinical Trials
123 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have advanced, large, or inoperable cancer in your throat or voice box (larynx) or in the area below your throat (hypopharynx).
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Boost Arm
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.