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NCT05544136 · ClinicalTrials.gov registry record · Phase 2
A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer
A Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 6
- Study locations
NCT05544136: Recruiting Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05544136 is a Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 12 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05544136, a Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. The study will look at how effective the treatment approach is against participants' cancer.
Primary Outcome
The primary objective is to assess the pilot efficacy of RT dose de-escalation to grossly involved lymph nodes for hypoxia negative T0-T3N1-2B HPV- OPC/UPC and HPC/LXC patients. For evaluation on the efficacy of the regimen in this cohort, a simple decision rule will be implemented as follows: If, among the first 10 evaluable patients, we have at least 8 patients who are alive, followed, and have major pathological response on planned neck dissection at 4 months ± 1 month post-CRT, then we will
Conditions Studied
Interventions
- DRUG Carboplatin
- DIAGNOSTIC_TEST 18F-FMISO PET/CT scan
- RADIATION Chemoradiation therapy
Study Locations (6)
New Jersey
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
New York
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-09-12 |
| Est. Completion | 2027-03-12 |
| Phase | Phase 2 |
What NCT05544136 shows while recruiting
NCT05544136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT05544136 lists 6 locations in 2 states (New Jersey, New York).
Frequently Asked Questions
What is clinical trial NCT05544136 about?
NCT05544136 is a clinical study titled "A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer". The purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. The study will look at how effective the treatment approach is against participants' cancer.
What is the current status of trial NCT05544136?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2022-09-12. Estimated completion is 2027-03-12.
What conditions does trial NCT05544136 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma, Head and Neck Neoplasms.
What interventions are being tested in trial NCT05544136?
The interventions under investigation include: Carboplatin (DRUG), 18F-FMISO PET/CT scan (DIAGNOSTIC_TEST), Chemoradiation therapy (RADIATION).
Who is sponsoring clinical trial NCT05544136?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05544136 being conducted?
This trial has 6 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05544136's enrollment target sits among peer trials
12 232nd of 250 higher than 15 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck 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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