Protocol Summary

Protocol No.

103976 (IIT NOVEMBER)

Principal Investigator

Poppe, Matthew

Phase

II

Age Group

Adult

ClinicalTrials.Gov

NCT03345420 (Click to jump to clinicaltrials.gov)

Eligibility Detail

Title

Phase II Trial of a 9-Day Course of Whole Breast Radiotherapy for Early Stage Breast Cancer

Objective

Primary Objectives and Endpoint
* To evaluate 24 month breast photographic cosmetic scores with 9 fraction radiation compared to standard hypofractionation.

Secondary Objectives and Endpoint
* To evaluate Breast-Q Patient Reported Outcomes (PROs)compared to historical control in breast conservation.
* To evaluate the incidence of acute and late radiation complications, based on CTCAE 4.0 toxicity.
* To evaluate the local and local regional recurrence rate.
* To compare the direct and indirect patient costs for radiation therapy compared to historical controls.

Applicable Disease Sites

Breast

Participating Institutions

HCI Farmington; HCI South Jordan; HCI Sugar House; Huntsman Cancer Institute

Status

Open


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