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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 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.

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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.

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

FieldValue
Enrollment Target 150 participants
Start Date 2022-07-20
Est. Completion 2030-12-31
Phase Phase 2

Sponsor

Heath Skinner

3 total trials

What the Registry Record Tells You About NCT05388773

The ClinicalTrials.gov registry entry for NCT05388773 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 126-participant average among 26 other Oropharynx Cancer trials with a reported enrollment target (19% higher). The listed sponsor is Heath Skinner, which has 3 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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