A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN

NCT02126969 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-03-13

Study results available
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Summary

The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this effect differs from the cellular effect of higher, standard fractions of radiation used in traditional radiation treatment paradigms.

Conditions

Interventions

RADIATION

Low dose fractionated radiation - 80cGy with chemotherapy

Chemotherapy + 80 cGy of RT

DRUG

Docetaxel and Carboplatin AUC 6

Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation

Sponsors & Collaborators

  • Susanne Arnold

    lead OTHER

Principal Investigators

  • Susanne M Arnold, MD · Lucille P. Markey Cancer Center at University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-03-31
Completion
2021-06-15

Countries

  • United States

Study Locations

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Entities

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 NCT02126969 on ClinicalTrials.gov