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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 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 30 participants.

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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.

Interventions

  • DRUG Cisplatin
  • DRUG Fluorouracil
  • DRUG Cetuximab
  • DRUG paclitaxel albumin-stabilized nanoparticle formulation
  • RADIATION Intensity modulated radiation therapy

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-08-09
Est. Completion 2019-10-31
Phase Phase 2

What the Registry Record Tells You About NCT01566435

The ClinicalTrials.gov registry entry for NCT01566435 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.

NCT01566435 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.