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Surgery + Reduced-Dose Radiation Therapy for Oropharyngeal Cancer
Phase 2
Recruiting
Led By Heath Skinner, MD, PhD
Research Sponsored by Heath Skinner
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be deemed eligible for a TOS procedure with no evidence of distant metastasis as determined by imaging studies
Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (before treatment), at 4-8 weeks post-surgery, at 1 year, up to 2 years following treatment
Awards & highlights
Study Summary
This trial is studying patients with HPV positive oropharyngeal cancer to see what the best treatment is following surgery.
Who is the study for?
This trial is for adults with HPV-positive oropharyngeal cancer that can be surgically removed. Participants must have no prior radiation above the clavicles, a specific tumor stage (III, IVa, or IVb without distant metastases), and good heart, kidney, and liver function. They should not have had another cancer in the last two years (with some exceptions) and must be generally fit (ECOG 0-1). Pregnant women and individuals with uncontrolled diabetes or hypertension are excluded.Check my eligibility
What is being tested?
The study tests transoral surgery followed by different treatments based on risk level: low-risk patients get no further treatment; intermediate-risk receive Intensity Modulated Radiotherapy (IMRT); high-risk get IMRT plus chemotherapy. The aim is to see if less aggressive therapy after surgery works well for certain risk groups.See study design
What are the potential side effects?
Potential side effects include those from surgical procedures such as pain and infection risks; IMRT may cause skin irritation, fatigue, dry mouth/throat; chemotherapy could lead to nausea/vomiting, hair loss, increased infection risk due to lowered blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for a TOS procedure and have no signs of cancer spread in my body.
Select...
My throat cancer is HPV-related, confirmed by a specific protein test.
Select...
I have a newly diagnosed, treatable throat cancer.
Select...
I am fully active or able to carry out light work.
Select...
I have not had radiation therapy above my collarbone.
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My kidney and liver functions are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (before treatment), at 4-8 weeks post-surgery, at 1 year, up to 2 years following treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (before treatment), at 4-8 weeks post-surgery, at 1 year, up to 2 years following treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence-Free Survival (RFS)
Secondary outcome measures
Adverse Events Related to Treatment
Assessment of PEG tube dependence
Distribution of patients based on histologic risk features
+12 moreSide effects data
From 2022 Phase 3 trial • 289 Patients • NCT0167289277%
Diarrhea
73%
Fatigue
39%
Nausea
37%
Abdominal pain
30%
Urinary frequency
21%
Anemia
21%
Constipation
21%
Anorexia
18%
Urinary incontinence
18%
Pelvic pain
17%
White blood cell decreased
16%
Edema limbs
16%
Pain
13%
Dyspnea
13%
Vomiting
13%
Headache
12%
Paresthesia
11%
Lymphocyte count decreased
10%
Bloating
10%
Hypomagnesemia
10%
Urinary tract pain
10%
Urinary urgency
10%
Urinary tract infection
10%
Cough
10%
Hot flashes
10%
Insomnia
9%
Platelet count decreased
9%
Rectal pain
8%
Gastrointestinal disorders - Other
8%
Proctitis
8%
Hyperglycemia
8%
Hyponatremia
8%
Anxiety
8%
Renal and urinary disorders - Other
8%
Weight loss
7%
Depression
7%
Cystitis noninfective
7%
Alopecia
6%
Tinnitus
6%
Blurred vision
6%
Neutrophil count decreased
6%
Hypokalemia
6%
Back pain
6%
Generalized muscle weakness
6%
Peripheral sensory neuropathy
6%
Vaginal discharge
6%
Vaginal hemorrhage
6%
Pruritus
6%
Hypertension
6%
Dermatitis radiation
6%
Dyspepsia
6%
Hypoalbuminemia
4%
Rectal hemorrhage
3%
Vaginal stricture
3%
Arthralgia
2%
Skin and subcutaneous tissue disorders - Other
1%
Device related infection
1%
Vaginal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intensity-Modulated Radiation Therapy
Standard Radiation Therapy
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm S (Low Risk)Experimental Treatment3 Interventions
Low risk patients are defined as T1-T2 AND 0 or 1 metastatic lymph nodes AND <3 cm AND clear (≥3mm) margins AND no extracapsular extension (ECE) AND no perineural invasion AND no lymphovascular invasion.
Patients will undergo transoral surgical resection of the oropharyngeal tumor.
Group II: Arm RT (Intermediate Risk)Experimental Treatment4 Interventions
Intermediate risk patients are defined as having any of the following features: One or more close (<3mm) margins, OR "minimal" ≤1 mm ECE OR 1 or more metastatic lymph nodes >3 cm in diameter OR 2-4 lymph nodes positive (≤ 6 cm in diameter), OR perineural invasion OR lymphovascular invasion
Patients will undergo transoral surgical resection of the oropharyngeal tumor. Following surgery, patients will receive low-dose IMRT five times a week for 3 weeks.
Group III: Arm CRT (High Risk)Experimental Treatment6 Interventions
High risk patients are defined as having any of the following features: One or more positive margins OR >1 mm ECE OR ≥ 5 metastatic lymph nodes.
Patients will undergo transoral surgical resection of the oropharyngeal tumor. Following surgery, patients will receive low-dose IMRT six times a week and a weekly chemotherapy infusion (cisplatin or carboplatin) during radiation therapy.
Patients will receive 2 Gy/fraction, 6 fractions per week with at least a 6-hour interfraction interval between each treatment:
PTV-P50 or PTV-N50: 50 Gy in 25 fractions (2 Gy/fx)
PTV-N45: 45 Gy in 25 fractions (1.8 Gy/fx) with simultaneous integrated boost to the PTV-P50 volume.
PTV-P30 or PTV-N30: 30 Gy in 15 fractions (2 Gy/fx)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
intensity-modulated radiation therapy
2008
Completed Phase 3
~1490
therapeutic conventional surgery
2003
Completed Phase 3
~12270
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Heath SkinnerLead Sponsor
3 Previous Clinical Trials
176 Total Patients Enrolled
Heath Skinner, MD, PhDPrincipal InvestigatorUPMC Hillman Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any health issues that could affect my treatment or surgery.I am eligible for a TOS procedure and have no signs of cancer spread in my body.My throat cancer is HPV-related, confirmed by a specific protein test.I have had serious heart or stroke issues in the last 6 months.My throat cancer is confirmed to be p16 positive.I have a newly diagnosed, treatable throat cancer.I am fully active or able to carry out light work.I have not had radiation therapy above my collarbone.I've been cancer-free for 2 years, except for certain skin cancers or early-stage cervical cancer.I don't have uncontrolled diabetes, infections despite antibiotics, or high blood pressure in the last 30 days.My kidney and liver functions are within normal ranges.My scans show no large or stuck together lymph nodes.
Research Study Groups:
This trial has the following groups:- Group 1: Arm S (Low Risk)
- Group 2: Arm RT (Intermediate Risk)
- Group 3: Arm CRT (High Risk)
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.
Has intensity-modulated radiation therapy acquired sanction from the Food and Drug Administration?
"Our estimation of intensity-modulated radiation therapy's safety is a 2, as the Phase 2 trial did not offer proof of efficacy but had several rounds demonstrating its security."
Answered by AI
What is the enrollment capacity of this clinical trial?
"Yes, the data posted on clinicaltrials.gov states that recruitment for this trial is ongoing. This research was initially published June 27th 2022 and has been revised as recently as October 4th 2022. The study requires 150 participants to be enrolled from a single medical centre."
Answered by AI
Is the application process now open for those interested in participating in this research?
"According to clinicaltrials.gov, this medical trial is still recruiting volunteers who are willing to participate in it; the initial announcement was made on June 27th 2022 and the information was recently amended for accuracy on October 4th of the same year."
Answered by AI
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