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Proton Beam Therapy

Radiation Therapy for Oropharyngeal Cancer

Phase 2 & 3
Waitlist Available
Led By Steven J. Frank, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Concurrent chemotherapy
Histologically documented squamous cell carcinoma of the oropharynx (AJCC version 7 stage III-IV A,B)
Must not have
Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease including but not limited to symptomatic congestive heart failure, unstable angina, cardiac dysrhythmia not controlled by pacer device, recent myocardial infarction, distant metastases, previous surgical resection or neck dissection for oropharyngeal cancer with therapeutic intent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two types of radiation therapy in treating patients with oropharyngeal cancer.

Who is the study for?
This trial is for adults with stage III-IVB oropharyngeal cancer who can provide tumor tissue for testing. They should have an ECOG performance status of 0, 1, or 2 and be able to undergo concurrent chemotherapy and bilateral neck radiation. Pregnant women, those with recent heart issues, previous head and neck radiation within five years, distant metastases, uncontrolled major diseases or prior surgical resection for their cancer are excluded.
What is being tested?
The study compares two types of radiation therapy: intensity-modulated proton beam therapy versus intensity-modulated photon therapy. It aims to determine which method is more effective in treating patients with advanced oropharyngeal cancer while also assessing side effects and impact on quality of life.
What are the potential side effects?
Potential side effects include skin reactions at the treatment site, dry mouth or throat due to salivary gland damage, difficulty swallowing from esophageal inflammation, fatigue from the body's response to radiation treatment as well as possible secondary cancers from exposure to ionizing radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently receiving chemotherapy.
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My cancer is a type of throat cancer called squamous cell carcinoma.
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I can take care of myself and am up and about more than half of my waking hours.
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I am not pregnant.
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I have received radiation therapy on both sides of my neck.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had radiation for head or neck cancer in the last 5 years.
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I do not have uncontrolled heart, lung, kidney, liver, stomach, or blood diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative incidence of acute grade 3+ toxicity (Phase II)
Cumulative incidence of late onset grade 3+ toxicity anytime (Phase II)
Overall survival (OS) (Phase II)
+2 more
Secondary study objectives
Quality of life (QoL) (Phase II and III)

Side effects data

From 2013 Phase 3 trial • 637 Patients • NCT00884741
30%
Fatigue
20%
Thrombosis
20%
Nausea
20%
Hemoglobin decreased
20%
Lymphopenia
20%
Alanine aminotransferase increased
20%
Hyperglycemia
20%
Hyponatremia
20%
Seizure
10%
Alopecia
10%
Weight loss
10%
Opportunistic infection
10%
Dry mouth
10%
Wound infection [with normal or Grade 1-2 ANC]
10%
Wound infection [with unknown ANC]
10%
Vascular access complication
10%
Wound dehiscence
10%
Dysphagia
10%
Acoustic nerve disorder NOS
10%
Anorexia
10%
Dehydration
10%
Eye disorder
10%
Disease progression
10%
Headache
10%
Hearing loss
10%
Tinnitus
10%
Fracture
10%
Creatinine increased
10%
Hyperkalemia
10%
Hypermagnesemia
10%
Hypoalbuminemia
10%
Muscle weakness left-sided
10%
Memory impairment
10%
Neurological disorder NOS
10%
Taste alteration
10%
Depression
10%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pre-Randomization TMZ+RT
Randomized Arm 1: TMZ+RT + Placebo
Randomized Arm 2: TMZ+RT + Bevacizumab

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: Arm II (IMPT)Experimental Treatment4 Interventions
Patients undergo IMPT QD five days a week for approximately 6.5 weeks.
Group II: Arm I (IMRT)Experimental Treatment4 Interventions
Patients undergo IMRT QD five days a week for approximately 6.5 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2140
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,368 Total Patients Enrolled
2 Trials studying Oropharyngeal Carcinoma
112 Patients Enrolled for Oropharyngeal Carcinoma
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,748 Total Patients Enrolled
2 Trials studying Oropharyngeal Carcinoma
209 Patients Enrolled for Oropharyngeal Carcinoma
National Institute of Dental and Craniofacial Research (NIDCR)NIH
307 Previous Clinical Trials
849,680 Total Patients Enrolled
Steven J. Frank, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
300 Total Patients Enrolled
Steven J FrankPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
5,691 Total Patients Enrolled

Media Library

Intensity-Modulated Proton Beam Therapy (IMPT) (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01893307 — Phase 2 & 3
Oropharyngeal Carcinoma Research Study Groups: Arm I (IMRT), Arm II (IMPT)
Oropharyngeal Carcinoma Clinical Trial 2023: Intensity-Modulated Proton Beam Therapy (IMPT) Highlights & Side Effects. Trial Name: NCT01893307 — Phase 2 & 3
Intensity-Modulated Proton Beam Therapy (IMPT) (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01893307 — Phase 2 & 3
~24 spots leftby Aug 2025
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