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NCT04900623 · ClinicalTrials.gov registry record · Phase 2
Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study
A Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, sponsored by Jonathan Schoenfeld, MD, MPH.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 145
- Enrollment target
- 2
- Study locations
NCT04900623 is a Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 that is actively recruiting participants, run by Jonathan Schoenfeld, MD, MPH. The registered enrollment target is 145 participants, above the 83-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (75% higher). The trial reports 2 study locations across 1 state.
The verdict
NCT04900623, a Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, is actively recruiting participants, sponsored by Jonathan Schoenfeld, MD, MPH.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 145 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test. The names of the test and treatments involved in this study are: * NavDx® HPV ctDNA testing (HPV blood test) * Radiation therapy * Chemotherapy: Cisplatin, or Carboplatin and Paclitaxel (not all participants receive any or all of these agents)
Conditions Studied
Interventions
- RADIATION Radiotherapy
- DRUG Chemotherapy drug
- DEVICE NavDx HPV ctDNA Testing
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2021-07-02 |
| Est. Completion | 2032-06-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04900623
The ClinicalTrials.gov registry entry for NCT04900623 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 83-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (75% higher). The listed sponsor is Jonathan Schoenfeld, MD, MPH, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with HPV Positive Oropharyngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Radiotherapy is the first listed.
NCT04900623 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04900623 about?
NCT04900623 is a clinical study titled "Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study". This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test. The names of the test and treatments involved in this s...
What is the current status of trial NCT04900623?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 145 participants. The study started on 2021-07-02. Estimated completion is 2032-06-01.
What conditions does trial NCT04900623 study?
This clinical trial studies the following conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, HPV-Related Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04900623?
The interventions under investigation include: Radiotherapy (RADIATION), Chemotherapy drug (DRUG), NavDx HPV ctDNA Testing (DEVICE).
Who is sponsoring clinical trial NCT04900623?
This trial is sponsored by Jonathan Schoenfeld, MD, MPH, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04900623 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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