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NCT04106362 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma
A Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04106362: Clinical Trial Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT04106362 is a Phase 2 study that was terminated before completion, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04106362, a Phase 2 study, was terminated before completion, sponsored by Jonsson Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This phase II trial studies how well radiation therapy and cisplatin with or without cetuximab works in treating patients with human papillomavirus (HPV) positive, KRAS-variant stage III-IV oropharyngeal squamous cell carcinoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy, cisplatin, and cetuximab may work better in treating patients with HPV positive, KRAS-variant oropharyngeal squamous cell carcinoma compared to radiation therapy and cisplatin alone.
Primary Outcome
OS will be estimated in each study arm by Kaplan-Meier estimate. Summaries of the number and percentage of patients who have died, are still in survival follow-up, are lost to follow-up and have withdrawn consent will be provided along with median OS. Furthermore, a binomial test of proportions will be used to test difference in 2-year OS between the two arms. Exact tests and continuity correction strategies will be considered when appropriate.
Interventions
- DRUG Cisplatin
- OTHER Quality-of-Life Assessment
- BIOLOGICAL Cetuximab
- OTHER Questionnaire Administration
- RADIATION Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2023-05-23 |
| Phase | Phase 2 |
Why NCT04106362 stopped before completion
NCT04106362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT04106362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04106362 about?
NCT04106362 is a clinical study titled "Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma". This phase II trial studies how well radiation therapy and cisplatin with or without cetuximab works in treating patients with human papillomavirus (HPV) positive, KRAS-variant stage III-IV oropharyngeal squamous cell carcinoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrin...
What is the current status of trial NCT04106362?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2020-01-14. Estimated completion is 2023-05-23.
What interventions are being tested in trial NCT04106362?
The interventions under investigation include: Cisplatin (DRUG), Quality-of-Life Assessment (OTHER), Cetuximab (BIOLOGICAL), Questionnaire Administration (OTHER), Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04106362?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04106362's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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