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NCT02281955 · ClinicalTrials.gov registry record · Phase 2
De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
NCT02281955: Completed Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT02281955 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 115 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02281955, a Phase 2 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
Study Summary
The purpose of this research study is to learn about the effectiveness of using lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck. The cure rate for this type of cancer is estimated to be high, \> 90%. The standard treatment for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is performed afterwards. This standard regimen causes a lot of side effects and long term complications. This study is evaluating whether a lower dose of radiation and chemotherapy may provide a similar cure rate as the longer, more intensive standard regimen. Patients in this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy.
Primary Outcome
Progression Free Survival (PFS) was defined as the time from the beginning of treatment to cancer progression or death. The outcome measure will be reported as the proportion of patients with PFS at 2 years post-treatment.
Interventions
- RADIATION Intensity Modulated Radiotherapy (IMRT)
- DRUG Cisplatin (or alternative)
- PROCEDURE Assessment for surgical evaluation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2014-08 |
| Est. Completion | 2024-11-24 |
| Phase | Phase 2 |
What the finished NCT02281955 record still lists
NCT02281955 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 3 interventions - of which Intensity Modulated Radiotherapy (IMRT) is the first listed.
NCT02281955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02281955 about?
NCT02281955 is a clinical study titled "De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study". The purpose of this research study is to learn about the effectiveness of using lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck. The cure rate for this type of cancer...
What is the current status of trial NCT02281955?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2014-08. Estimated completion is 2024-11-24.
What interventions are being tested in trial NCT02281955?
The interventions under investigation include: Intensity Modulated Radiotherapy (IMRT) (RADIATION), Cisplatin (or alternative) (DRUG), Assessment for surgical evaluation (PROCEDURE).
Who is sponsoring clinical trial NCT02281955?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02281955's enrollment target sits among peer trials
115 626th of 2000 higher than 1,374 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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