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NCT02258659 · ClinicalTrials.gov registry record · Phase 2
Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer
A Phase 2 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT02258659: Completed Phase 2 study, sponsored by University of Chicago.
NCT02258659 is a Phase 2 study that has completed, run by University of Chicago. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02258659, a Phase 2 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
This phase II trial studies nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) and carboplatin followed by response-based local therapy in treating patients with stage III or IV human papillomavirus (HPV)-related oropharyngeal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, hydroxyurea, fluorouracil, paclitaxel, and 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 spreading. Radiation therapy uses high energy x rays to kill tumor cells. Giving nab-paclitaxel and carboplatin before chemoradiation may make the tumor smaller and reduce the amount of chemotherapy and radiation therapy needed. Assigning chemotherapy and radiation therapy based on response (response-based therapy) and giving patients who are responding well lower doses of treatment may help reduce the occurrence of side effects.
Primary Outcome
If all patients are followed for two years, the PFS rate and confidence interval will be determined based on the exact binomial distribution. Otherwise, PFS will be estimated using the Kaplan-Meier method and a (large-sample) one-sided 90% confidence interval will be derived for the PFS rate at two years to test the non-inferiority hypothesis. Median PFS will be estimated as described in Brookmeyer and Crowley.
Interventions
- DRUG carboplatin
- DRUG paclitaxel
- DRUG fluorouracil
- RADIATION radiation therapy
- DRUG paclitaxel albumin-stabilized nanoparticle formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2014-09-22 |
| Est. Completion | 2024-09-06 |
| Phase | Phase 2 |
What the finished NCT02258659 record still lists
NCT02258659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 5 interventions - of which carboplatin is the first listed.
NCT02258659 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02258659 about?
NCT02258659 is a clinical study titled "Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer". This phase II trial studies nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) and carboplatin followed by response-based local therapy in treating patients with stage III or IV human papillomavirus (HPV)-related oropharyngeal cancer. Drugs used in chemotherapy, such as paclitax...
What is the current status of trial NCT02258659?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2014-09-22. Estimated completion is 2024-09-06.
What interventions are being tested in trial NCT02258659?
The interventions under investigation include: carboplatin (DRUG), paclitaxel (DRUG), fluorouracil (DRUG), radiation therapy (RADIATION), paclitaxel albumin-stabilized nanoparticle formulation (DRUG).
Who is sponsoring clinical trial NCT02258659?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02258659's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 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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