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Radiation Therapy
Reduced Intensity Radiation for Head and Neck Cancer
Phase 2
Waitlist Available
Led By Wade Thorstad, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or hypopharynx treated with surgical resection with one (or both) side(s) of the neck pathologically N0
Indication for radiation therapy at the primary site or neck with specific characteristics including close margin (<= 0.5 cm), positive margin, perineural invasion, lymphovascular space invasion, metastatic disease in more than one lymph node, metastatic disease in more than one lymph node group, extracapsular extension in any lymph node, or considered at risk based on multi-disciplinary tumor board discussion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of follow-up (minimum of 5 years from completion of treatment)
Awards & highlights
Study Summary
This trial is testing whether reducing radiation to parts of the neck without cancer can help spare side effects from radiation for head and neck cancer.
Who is the study for?
This trial is for adults over 18 with certain types of head and neck cancer, specifically in the oral cavity, oropharynx, larynx, or hypopharynx. They should have had surgery already and show no signs of cancer on one or both sides of their neck. The trial isn't open to those who've had previous head and neck cancers (except non-melanoma skin cancer), prior head and neck surgeries, or women who are pregnant or nursing.Check my eligibility
What is being tested?
The study is testing whether reducing radiation therapy to areas without evident cancer can lessen side effects for patients with head and neck cancer. It involves adjusting the amount of radiation away from healthy tissue after surgical removal of tumors.See study design
What are the potential side effects?
While not explicitly listed here, common side effects from intensity modulated radiation therapy may include skin changes similar to sunburns, fatigue, dry mouth/throat issues due to less saliva production, difficulty swallowing, taste changes, and potential dental problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer in the mouth or throat was surgically removed and did not spread to my neck.
Select...
I need radiation therapy due to certain high-risk features of my cancer.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of follow-up (minimum of 5 years from completion of treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of follow-up (minimum of 5 years from completion of treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With a Recurrence in the Unirradiated Neck(s)
Secondary outcome measures
Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms
Disease Specific Survival Rate
Kaplan Meier Estimate of Locoregional Recurrence Free Survival
+4 moreSide effects data
From 2016 Phase 2 trial • 68 Patients • NCT0005778590%
Dry mouth
87%
Salivary gland disorder NOS
75%
Hemoglobin decreased
75%
Late RT toxicity: Salivary gland: NOS
74%
Radiation mucositis
74%
Fatigue
74%
Leukopenia NOS
68%
Nausea
63%
Dermatitis radiation NOS
60%
Late RT toxicity: Mucous membrane: NOS
59%
Weight decreased
49%
Late RT toxicity: Other: NOS
49%
Hearing impaired
49%
Neutropenia
47%
Late RT toxicity: Auditory/hearing: NOS
46%
Vomiting NOS
41%
Late RT toxicity: Esophagus: NOS
41%
Esophagitis NOS
40%
Late RT toxicity: Subcutaneous tissue (within RT field): NOS
38%
Hyponatremia
35%
Pain due to radiation
35%
Dysphagia
35%
Pain-other
34%
Peripheral sensory neuropathy
32%
Late RT toxicity: Skin (within RT field): NOS
29%
Alopecia
28%
Taste disturbance
28%
Blood albumin decreased
28%
Dehydration
26%
Anorexia
26%
Platelet count decreased
25%
Hearing-Other
25%
Hypocalcemia
24%
Lymphopenia
24%
Hyperglycemia NOS
22%
Stomatitis
22%
Blood magnesium decreased
22%
Epistaxis
22%
Hypokalemia
21%
Constipation
19%
Edema NOS
19%
Renal/GU-Other
19%
Late RT toxicity: Joint: NOS
19%
Late RT toxicity: Larynx: NOS
19%
Alanine aminotransferase increased
18%
Blood creatinine increased
16%
Cough
15%
Pyrexia
15%
Hypothyroidism
15%
Headache NOS
13%
Diarrhea NOS
13%
Skin discoloration
13%
Aspartate aminotransferase increased
13%
Blood alkaline phosphatase NOS increased
12%
Hematologic-Other
12%
GI-other
12%
Skin-Other
10%
Infection NOS
10%
Metabolic-Other
10%
Otitis media serous NOS
10%
Hyperkalemia
9%
Blood bilirubin increased
9%
Peripheral motor neuropathy
9%
Esophageal spasm
9%
Hypotension NOS
9%
Hypophosphatemia
9%
Dyspnea NOS
9%
Dermatitis exfoliative NOS
9%
Erythema multiforme
7%
Gamma-glutamyltransferase increased
7%
Dysphonia
7%
Hiccups
7%
Rhinitis allergic NOS
7%
Rigors
6%
Insomnia NEC
6%
Late RT toxicity: Bone (incl. osteonecrosis): NOS
6%
Confusion
6%
Packed red blood cell transfusion
6%
Infection with grade 3 or 4 neutropenia
6%
Earache
6%
Dizziness (exc vertigo)
6%
Neuralgia NOS
6%
Pulmonary-other
6%
Toxicoderma
6%
Joint, muscle, or bone-Other
4%
Febrile neutropenia
4%
Pneumonitis NOS
4%
Hypoxia
4%
Syncope
3%
Infection, Other
3%
Endocrine-Other
3%
Otitis externa (exc boil of meatus) NOS
3%
Hallucination NOS
1%
Neurologic-Other
1%
Infection with unknown ANC
1%
Ventricular arrhythmia NOS
1%
Tumour pain
1%
Sinus tachycardia
1%
Supraventricular arrhythmia NOS
1%
Implant infection
1%
CD4 lymphocytes decreased
1%
Leukocytes for BMT
1%
Weight increased
1%
Acidosis NOS
1%
Hemorrhage NOS
1%
Thrombosis NOS
1%
Inappropriate ADH secretion
1%
Left ventricular failure
1%
Anxiety NEC
1%
Depression NEC
1%
Renal failure NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
IMRT +/- Chemotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intensity modulated radiation therapy (IMRT)Experimental Treatment1 Intervention
-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity modulated radiation therapy
2003
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,621 Total Patients Enrolled
1 Trials studying Laryngeal Cancer
10 Patients Enrolled for Laryngeal Cancer
Wade Thorstad, MDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
5 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my head or neck before.My cancer in the mouth or throat was surgically removed and did not spread to my neck.I need radiation therapy due to certain high-risk features of my cancer.I am 18 years old or older.I have had head and neck cancer before, but not skin cancer.I am not pregnant or nursing.
Research Study Groups:
This trial has the following groups:- Group 1: Intensity modulated radiation therapy (IMRT)
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.
Are there any vacancies available in this research initiative?
"This specific medicinal study, which was first publicized on April 11th 2007 is not presently recruiting patients. However, there are 37 other active clinical trials actively seeking participants."
Answered by AI
What potential health risks exist for those receiving Intensity modulated radiation therapy?
"Based on the data available, our team at Power assigned Intensity modulated radiation therapy a rating of 2 out of 3 points. This marks this Phase 2 trial as having some evidence backing safety but no established efficacy yet."
Answered by AI
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