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Platinum-based Chemotherapy
Neck Radiation +/− Cisplatin for Oropharyngeal Cancer
Phase 2
Recruiting
Led By Thomas Galloway, MD
Research Sponsored by Fox Chase 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 2 years
Awards & highlights
Study Summary
This trial looks at treatment options for throat cancer with no spread to other parts of the body.
Who is the study for?
This trial is for adults with p16+ oropharyngeal cancer, who have not had prior systemic therapy or neck surgery for the cancer. They should be in good physical condition (ECOG 0-1), without metastatic disease, bilateral neck adenopathy, or a history of severe allergic reactions to Technetium-99m-tilmanocept. Tumors must not cross midline and patients should have adequate organ function.Check my eligibility
What is being tested?
The study tests elective neck radiation directed by lymphoscintigraphy in p16+ favorable risk oropharynx cancer patients. It's a phase II trial where participants receive either 6 weeks of daily radiation with cisplatin, or an extended 7-week course if needed based on tumor mapping.See study design
What are the potential side effects?
Potential side effects include skin irritation at the radiation site, fatigue, dry mouth, difficulty swallowing due to inflammation of throat tissues, altered taste sensation and potential hearing loss from cisplatin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients that develop cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment
Secondary outcome measures
Disease free survival (DFS)
Dosimetric degree of normal tissue avoidance
Level of xerostomia
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B (N0 or N1 <3cm)Experimental Treatment1 Intervention
For Cohort B patients need to have either no lymph nodes or only one lymph node adenopathy, provided it is smaller than 3cm.
Group II: Cohort A (>N1 or single node > 3cm )Experimental Treatment2 Interventions
More extensive neck involvement or proximity to the midline can qualify a patient in cohort A. Cohort A will have patients with either more than one lymph node adenopathy or 1 lymph node that is large (>3cm).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,516 Total Patients Enrolled
Cardinal HealthIndustry Sponsor
10 Previous Clinical Trials
2,145 Total Patients Enrolled
Thomas Galloway, MDPrincipal InvestigatorFox Chase Cancer Center
1 Previous Clinical Trials
2 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received systemic therapy for my cancer.My blood, kidney, and liver tests are normal.I do not have any unmanaged ongoing illnesses.I had surgery for head or neck cancer that involved my neck.My cancer is p16-negative squamous cell carcinoma.My cancer has spread beyond its original site or I have swollen lymph nodes below my collarbone.My tumor has spread across the center of my body.My cancer is a type of throat cancer called squamous cell carcinoma.I am 18 years old or older.My test shows strong p16 presence in most of my cells.I have been mostly active and able to carry on all pre-disease activities without restriction in the last 56 days.I've had radiation therapy to my head or neck that overlapped areas.My cancer has spread to nearby lymph nodes.My cancer is near the center of my body and I need radiation on both sides of my neck.My primary cancer site was completely removed before my evaluation.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A (>N1 or single node > 3cm )
- Group 2: Cohort B (N0 or N1 <3cm)
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 the FDA officially sanctioned Cohort B (N0 or N1 <3cm)?
"The safety of Cohort B (N0 or N1 <3cm) is estimated to be a 2, as this Phase 2 trial has limited data suggesting its efficacy but some evidence demonstrating that it can be safely administered."
Answered by AI
Are fresh participants currently being enrolled for this trial?
"Affirmative, the information available on clinicaltrials.gov notes that this trial is actively seeking participants at present. Initially posted on March 14th 2023, it underwent its most recent update April 5th of the same year and requires 22 individuals from a single medical facility to take part in the study."
Answered by AI
What is the largest possible cohort of individuals included in this medical study?
"Affirmative. As indicated by clinicaltrials.gov, this investigation is currently recruiting patients; it was first publicized on March 14th 2023 and revised most recently on April 5th 2023. The study aims to recruit 22 individuals across a single medical centre."
Answered by AI
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