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A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT)

NCT01820312 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-08-08

No results posted yet for this study

Summary

The purpose of this study is to determine if low-dose radiation therapy and the chemotherapy drug paclitaxel is effective in treating head and neck cancer that has returned after treatment with standard radiation therapy alone, but cannot be removed by surgery. The overall total dose received of both the chemotherapy and radiation therapy will be less than that typically given as standard of care; however, the Food and Drug Administration (FDA) has not evaluated the safety and effectiveness of this combination therapy. In addition, this study will gather information about the effects of radiation therapy and chemotherapy on subject's overall quality of life.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

RADIATION

Low-Dose Fractionated Radiation Therapy/Paclitaxel

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Jose Penagaricano, MD · University of Arkansas

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

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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 NCT01820312 on ClinicalTrials.gov