← Back to Search

Alkylating agents

Neck Dissection for Oropharyngeal Carcinoma

Phase 2
Waitlist Available
Led By Paul Swiecicki, 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
Awards & highlights

Study Summary

This study is evaluating whether a surgery to remove the lymph nodes in the neck can improve quality of life for people with oropharyngeal cancer.

Eligible Conditions
  • Oropharyngeal Carcinoma

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment
Secondary outcome measures
Disease Specific Survival (DSS)
Impact of Neck Dissection on Shoulder Function Using the Neck Dissection Impairment Index
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment
+2 more
Other outcome measures
Financial Toxicity

Side effects data

From 2022 Phase 2 trial • 40 Patients • NCT02784288
59%
Dry mouth
56%
Dysgeusia
50%
Dysphagia
44%
Nausea
41%
Constipation
41%
Oral pain
41%
Pain
41%
Weight loss
41%
Fatigue
38%
Mucositis oral
32%
Dermatitis radiation
29%
General disorders and administration site conditions- Other
29%
Sore throat
26%
Neck pain
21%
Vomiting
18%
Hypertension
18%
Trismus
18%
Anorexia
18%
Dehydration
18%
Hoarseness
18%
Lymphedema
18%
Myalgia
18%
Esophageal pain
15%
Ear pain
15%
Musculoskeletal and connective tissue disorder - Other
12%
Anxiety
12%
Depression
12%
Infections and infestations - Other
12%
Insomnia
12%
Voice alteration
12%
Headache
9%
Muscle weakness upper limb
9%
Anemia
9%
Hearing impaired
9%
Lymphocyte count decreased
9%
Paresthesia
9%
Skin and subcutaneous tissue disorders - Other
9%
Dizziness
9%
Gastroesophageal reflux disease
6%
Gastrointestinal disorders - Other
6%
Laryngeal inflammation
6%
Stomach pain
6%
Syncope
6%
Upper respiratory infection
6%
Oral Hemorrhage
6%
Back Pain
6%
Hypothyroidism
6%
Joint range of motion decreased lumbar spine
6%
Meningismus
6%
Metabolism and nutrition disorders - Other
6%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
6%
Non-cardiac chest pain
6%
Pain in extremity
6%
Productive cough
6%
Rash maculo-papular
6%
Renal and urinary disorders - Other
6%
Diarrhea
6%
Generalized muscle weakness
6%
Nasal congestion
6%
Facial pain
6%
Sleep apnea
3%
Aspiration
3%
Hyperglycemia
3%
Muscle weakness lower limb
3%
Muscle weakness trunk
3%
Superficial soft tissue fibrosis
3%
Localized edema
3%
Spinal fracture
3%
Testicular disorder
3%
Tinnitus
3%
Surgical and medical procedures - Other
3%
Urinary retention
3%
Blood bilirubin increased
3%
Abdominal pain
3%
Alkaline phosphatase increased
3%
Alopecia
3%
Arthralgia
3%
Arthritis
3%
Avascular necrosis
3%
Bronchial obstruction
3%
Buttock pain
3%
Cardiac disorders- Other
3%
chest wall pain
3%
Cough
3%
Creatinine increased
3%
Dyspnea
3%
Ear and labyrinth disorders - Other
3%
Edema face
3%
Hot flashes
3%
Hypomagnesemia
3%
Hyponatremia
3%
Hypotension
3%
Injury, poisoning and procedural complications - Other
3%
Mucosal infection
3%
Oral dysesthesia
3%
Osteoporosis
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Palpitations
3%
Pancreatitis
3%
Papulopustular rash
3%
Peripheral motor neuropathy
3%
Personality change
3%
Postoperative hemorrhage
3%
Pulmonary fibrosis
3%
Rash acneiform
3%
Seroma
3%
Vertigo
3%
Weight gain
3%
White blood cell decreased
3%
Dry skin
3%
Edema limbs
3%
Esophageal ulcer
3%
Esophagitis
3%
Facial muscle weakness
3%
Flank pain
3%
Hypocalcemia
3%
Skin infection
3%
Skin ulceration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Neck Dissection

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neck DissectionExperimental Treatment6 Interventions
Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
SOC Radiation
2016
Completed Phase 2
~40
Carboplatin
FDA approved
Videofluoroscopy
2016
Completed Phase 2
~70
Neck Dissection
2015
Completed Phase 2
~50
Standard-of-Care (SOC) Transoral Surgery of Primary Site
2016
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,081 Total Patients Enrolled
Paul Swiecicki, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center
3 Previous Clinical Trials
69 Total Patients Enrolled

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
Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients With HPV+ Oropharyngeal Squamous Cell Cancer
2016. "Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients With HPV+ Oropharyngeal Squamous Cell Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02784288.
~5 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top