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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 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 115 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02281955
The ClinicalTrials.gov registry entry for NCT02281955 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Intensity Modulated Radiotherapy (IMRT) is the first listed.
NCT02281955 reports 0 study locations.
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.
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