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Hypofractionated Reduced-Volume Chemoradiation for T1/2N0-2 SCC Head and Neck

NCT02201355 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-02-02

No results posted yet for this study

Summary

Primary Objectives:

To determine whether patients with T1/2N0-2 Squamous Cell Carcinoma of the oropharynx, hypopharynx or larynx can tolerate treatment with cisplatin chemoradiation in three weeks using reduced volume IMRT

Secondary Objectives:

To describe the adverse events associated with hypofractionated, reduced volume cisplatin chemoradiation.

To estimate response rates and progression-free survival rates of hypofractionated, reduced volume cisplatin chemoradiation.

To determine HRQOL following hypofractionated, reduced volume cisplatin chemoradiation.

If patients can safely be treated in three weeks rather than six weeks, such a schedule would provide a much more convenient alternative for patients and result in a significant reduction in the health care resources currently expended on cure of these patients.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck T1/2N0-2

Interventions

RADIATION

Intensity Modulated Radiotherapy

Patients treated five fractions per week with radiotherapy dose per fraction and cisplatin dose increased according to the treatment table

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Lucien Nedzi, MD · UTSW

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-18
Primary Completion
2018-01-23
Completion
2020-05-15

Countries

  • United States

Study Locations

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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 NCT02201355 on ClinicalTrials.gov