MedTrace Logo

Induction Chemotherapy With ACF Followed by Chemoradiation Therapy for Adv. Head & Neck Cancer

NCT01566435 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-10-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Head and Neck Neoplasms

Interventions

DRUG

paclitaxel albumin-stabilized nanoparticle formulation

DRUG

Cisplatin

DRUG

Fluorouracil

RADIATION

Intensity modulated radiation therapy

DRUG

Cetuximab

PROCEDURE

Quality-of-life assessment

ACF baseline, IMRT baseline, Day 7, Week 12, months 6 and 12

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Douglas Adkins, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-09
Primary Completion
2013-10-31
Completion
2019-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01566435 on ClinicalTrials.gov