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NCT02994069 · ClinicalTrials.gov registry record · Phase 2
Cisplatin + Radiation in SCCHN and Correlation With Oxidative Stress Markers
A Phase 2 study of Head and Neck Cancer and Carcinoma, Squamous Cell, sponsored by Susanne Arnold.
- Active
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT02994069: Active Phase 2 study of Head and Neck Cancer and Carcinoma, Squamous Cell, sponsored by Susanne Arnold.
NCT02994069 is a Phase 2 study of Head and Neck Cancer and Carcinoma, Squamous Cell that is active but no longer recruiting, run by Susanne Arnold. The registered enrollment target is 80 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02994069, a Phase 2 study of Head and Neck Cancer and Carcinoma, Squamous Cell, is active but no longer recruiting, sponsored by Susanne Arnold.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients will receive standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin or every 3-week cisplatin in locally advanced SCCHN. The relationship between cisplatin toxicity and the level of reactive oxygen species generated by the drug in subjects with squamous cell carcinoma of the head and neck treated on this trial.
Primary Outcome
Rate of grade 3-5 cisplatin-related adverse events expressed as a percentage of each cohort of patients occurring within 90 days of initiation of concurrent radiation and chemotherapy; Rate calculated from number of patients with at least one cisplatin-related AEs with grade 3-5 within 90 days of the 1st treatment. This primary endpoint is the percentage of subjects experiencing cisplatin-related actual toxicities in each group estimated along with exact 95% binomial confidence intervals.
Conditions Studied
Interventions
- DRUG Cisplatin
- RADIATION XRT
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2017-04-11 |
| Est. Completion | 2029-10-31 |
| Phase | Phase 2 |
What the registry record for NCT02994069 still lists
NCT02994069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cisplatin is the first listed.
NCT02994069 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT02994069 about?
NCT02994069 is a clinical study titled "Cisplatin + Radiation in SCCHN and Correlation With Oxidative Stress Markers". Patients will receive standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin or every 3-week cisplatin in locally advanced SCCHN. The relationship between cisplatin toxicity and the level of reac...
What is the current status of trial NCT02994069?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2017-04-11. Estimated completion is 2029-10-31.
What conditions does trial NCT02994069 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Carcinoma, Squamous Cell.
What interventions are being tested in trial NCT02994069?
The interventions under investigation include: Cisplatin (DRUG), XRT (RADIATION).
Who is sponsoring clinical trial NCT02994069?
This trial is sponsored by Susanne Arnold, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02994069 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02994069's enrollment target sits among peer trials
80 97th of 250 higher than 153 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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