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Proton Beam Therapy
Proton Beam Radiation Therapy for Hypopharyngeal Cancer
Phase 1
Waitlist Available
Led By Clifton D Fuller
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
Inoperable locally advances disease, i.e. stage >= III and T stage >= 2
The primary radiotherapy, either in combination with chemotherapy or not, with curative intent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after radiation therapy
Awards & highlights
Study Summary
This trial looks at a new radiation schedule to kill cancer cells and shrink tumors in people with head and neck cancer that can't be surgically removed.
Eligible Conditions
- Oropharyngeal Carcinoma
- Nasopharyngeal Carcinoma
- Hypopharyngeal Cancer
- Laryngeal Cancer
- Head and Neck Squamous Cell Carcinoma
- Squamous Cell Carcinoma
- Head and Neck Cancers
- Laryngeal Squamous Cell Carcinoma
- Nasopharyngeal Cancer
- Oral Squamous Cell Carcinoma
- Oral Cancers
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Your cancer has spread too much and cannot be removed with surgery.
Select...
You have received radiation therapy as the main treatment, either with or without chemotherapy, aiming to cure your condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3-6 months after radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3-6 months after radiation therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of severe unacceptable local adverse events which are radio therapeutically attributable
Secondary outcome measures
Incidence of grade 3 toxicity
Side effects data
From 2020 Phase 2 trial • 35 Patients • NCT0207396871%
Cough
69%
Dysphagia
54%
Dermatitis
40%
Anorexia
23%
Constipation
11%
Dehydration
6%
Fatigue
6%
Nausea
6%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (PET-adjusted IMRT, Carboplatin, Paclitaxel)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (proton therapy)Experimental Treatment3 Interventions
Patients undergo radiation therapy QD 5 days a week (Monday through Friday) for the first 18 days and then BID for 15 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,446 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,643 Total Patients Enrolled
Clifton D FullerPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
150 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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