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NCT01566435 · ClinicalTrials.gov registry record · Phase 2
Induction Chemotherapy With ACF Followed by Chemoradiation Therapy for Adv. Head & Neck Cancer
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01566435: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT01566435 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01566435, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This phase II trial studies the safety and effectiveness of an induction chemotherapy (ACF) consisting of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), cisplatin and fluorouracil followed by chemoradiation therapy in treating patients with stage III-IV squamous cell cancer of the head and neck. ACF may be an effective way to reduce or downgrade locally aggressive tumors, and improve the chance of eradication by chemoradiation.
Primary Outcome
* Response will be assessed by laryngoscopy. * CR: disappearance of all lesions
Interventions
- DRUG Cisplatin
- DRUG Fluorouracil
- DRUG Cetuximab
- DRUG paclitaxel albumin-stabilized nanoparticle formulation
- RADIATION Intensity modulated radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-08-09 |
| Est. Completion | 2019-10-31 |
| Phase | Phase 2 |
What the finished NCT01566435 record still lists
NCT01566435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT01566435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01566435 about?
NCT01566435 is a clinical study titled "Induction Chemotherapy With ACF Followed by Chemoradiation Therapy for Adv. Head & Neck Cancer". This phase II trial studies the safety and effectiveness of an induction chemotherapy (ACF) consisting of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), cisplatin and fluorouracil followed by chemoradiation therapy in treating patients with stage III-IV squamous cell cancer...
What is the current status of trial NCT01566435?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2012-08-09. Estimated completion is 2019-10-31.
What interventions are being tested in trial NCT01566435?
The interventions under investigation include: Cisplatin (DRUG), Fluorouracil (DRUG), Cetuximab (DRUG), paclitaxel albumin-stabilized nanoparticle formulation (DRUG), Intensity modulated radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT01566435?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01566435's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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