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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Quality of life (QoL) (Phase II and III)
Side effects data
From 2013 Phase 3 trial • 637 Patients • NCT0088474130%
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%
Wound dehiscence
10%
Vascular access complication
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
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
~2160
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,341 Total Patients Enrolled
2 Trials studying Oropharyngeal Carcinoma
112 Patients Enrolled for Oropharyngeal Carcinoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,713 Total Patients Enrolled
2 Trials studying Oropharyngeal Carcinoma
152 Patients Enrolled for Oropharyngeal Carcinoma
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,172 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving chemotherapy.My cancer is a type of throat cancer called squamous cell carcinoma.I had radiation for head or neck cancer in the last 5 years.My tumor can be tested for HPV or p16, or I can have a biopsy if needed.I can take care of myself and am up and about more than half of my waking hours.I am not pregnant.I have received radiation therapy on both sides of my neck.I do not have uncontrolled heart, lung, kidney, liver, stomach, or blood diseases.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (IMRT)
- Group 2: Arm II (IMPT)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being welcomed into this clinical research project?
"442 patients that meet the pre-specified inclusion criteria are needed for this study. New york Proton Center in New York, New York and Northwestern Memorial Hospital in Chicago, Illinois are two of the many places where patients can choose to participate in this clinical trial."
Answered by AI
Could you tell us how many research centers are participating in this trial?
"Patients are currently being enrolled for this study at New york Proton Center, Northwestern Memorial Hospital, MD Anderson West Houston, and 27 other hospitals."
Answered by AI
Are new participants being allowed to join this trial at this time?
"Yes. The clinical trial is recruiting patients and was posted on 2013-08-26. The latest update was on 2022-05-13. The study needs 442 patients from 27 locations."
Answered by AI
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