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NCT05388773 · ClinicalTrials.gov registry record · Phase 2
Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
A Phase 2 study of Oropharynx Cancer, sponsored by Heath Skinner.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT05388773: Recruiting Phase 2 study of Oropharynx Cancer, sponsored by Heath Skinner.
NCT05388773 is a Phase 2 study of Oropharynx Cancer that is actively recruiting participants, run by Heath Skinner. The registered enrollment target is 150 participants, above the 126-participant average among 26 other Oropharynx Cancer trials with a reported enrollment target (19% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05388773, a Phase 2 study of Oropharynx Cancer, is actively recruiting participants, sponsored by Heath Skinner.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment.
Primary Outcome
Time to recurrence, defined as local and/or regional progression (identification of disease growth that is present within the area in which it was first located) and/or distant metastasis (identification of disease growth that is present in area(s) distant to that previously located). Local progression is defined as progression at the primary tumor site. Regional progression is defined as progression in the draining lymphatics (typically the cervical, retropharyngeal/retrostyloid and supraclavic
Conditions Studied
Interventions
- DRUG Cisplatin
- OTHER laboratory biomarker analysis
- PROCEDURE therapeutic conventional surgery
- OTHER quality-of-life assessment
- RADIATION intensity-modulated radiation therapy
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-07-20 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 2 |
What NCT05388773 shows while recruiting
NCT05388773 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 126-participant average among 26 other Oropharynx Cancer trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Oropharynx Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT05388773 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05388773 about?
NCT05388773 is a clinical study titled "Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer". This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patien...
What is the current status of trial NCT05388773?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2022-07-20. Estimated completion is 2030-12-31.
What conditions does trial NCT05388773 study?
This clinical trial studies the following conditions: Oropharynx Cancer.
What interventions are being tested in trial NCT05388773?
The interventions under investigation include: Cisplatin (DRUG), laboratory biomarker analysis (OTHER), therapeutic conventional surgery (PROCEDURE), quality-of-life assessment (OTHER), intensity-modulated radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT05388773?
This trial is sponsored by Heath Skinner, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05388773 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Oropharynx Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05388773's enrollment target sits among peer trials
150 3rd of 26 higher than 23 of 26 other Oropharynx Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oropharynx Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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