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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

Study Summary

This trial is testing whether giving higher doses of radiation to parts of the tumor that are hard to treat will improve cancer control in people with head and neck cancer.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Free Survival (DSF) time
Secondary outcome measures
Correlation coefficient between continuous dose and perfusion summary measures
Local-regional control rate
Number of patients with adverse events
+1 more

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
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
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
2,696 Previous Clinical Trials
6,952,473 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
23,991 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer
2014. "Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02031250.
~9 spots leftby Apr 2025
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