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NCT05491512 · ClinicalTrials.gov registry record · Phase 2
A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer
A Phase 2 study of Human Papilloma Virus and Oropharyngeal Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 121
- Enrollment target
- 7
- Study locations
NCT05491512: Recruiting Phase 2 study of Human Papilloma Virus and Oropharyngeal Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05491512 is a Phase 2 study of Human Papilloma Virus and Oropharyngeal Cancer that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 121 participants, below the 8,438-participant average among 39 other Human Papilloma Virus trials with a reported enrollment target (99% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05491512, a Phase 2 study of Human Papilloma Virus and Oropharyngeal Cancer, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 121 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane- (Albumin-bound Paclitaxel).
Primary Outcome
The primary objective of this protocol is to demonstrate that the 2 year locoregional control for these subjects treated with a major de-escalated radiation dose of 30Gy is acceptable as compared to historical locoregional control rate for subjects treated with the current standard chemoradiation at 70Gy. To examine if subjects receiving 30Gy have an acceptable treatment outcome when compared to the radiation of 70Gy both in the setting of concurrent chemotherapy, we will test the hypothesis tha
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- RADIATION Radiation
- DRUG 5-fluorouracil
- DIAGNOSTIC_TEST 18 F-FMISO PET/CT
Study Locations (7)
New York
- Memorial Sloan Kettering Cancer Center at Suffolk-Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2022-08-04 |
| Est. Completion | 2026-08-04 |
| Phase | Phase 2 |
What NCT05491512 shows while recruiting
NCT05491512 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 8,438-participant average among 39 other Human Papilloma Virus trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Human Papilloma Virus appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT05491512 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05491512 about?
NCT05491512 is a clinical study titled "A Study of Reduced Radiation Therapy and Standard-of-Care Chemotherapy in People With HPV-Positive Throat Cancer". The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluo...
What is the current status of trial NCT05491512?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2022-08-04. Estimated completion is 2026-08-04.
What conditions does trial NCT05491512 study?
This clinical trial studies the following conditions: Human Papilloma Virus, Oropharyngeal Cancer, Hpv, Oropharyngeal Carcinoma, Throat Cancer.
What interventions are being tested in trial NCT05491512?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Radiation (RADIATION), 5-fluorouracil (DRUG), 18 F-FMISO PET/CT (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05491512?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05491512 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05491512's enrollment target sits among peer trials
121 24th of 39 higher than 16 of 39 other Human Papilloma Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Papilloma Virus 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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