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Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients

NCT05253170 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 622

Last updated 2022-03-11

No results posted yet for this study

Summary

This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy and reconstruction surgery.

Conditions

Interventions

RADIATION

Hypofractionation

Radiation regimen of 2.5-3.0Gy x 13-17 fractions +/- sequential boost 0-7 fractions

RADIATION

Conventional Fractionation

Radiation regimen of 1.8-2.0Gy x 23-28 fractions +/- sequential boost 0-5 fractions

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • In Ah Kim, MD. PhD. · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2027-12-31
Completion
2032-12-31

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Entities

Diseases

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 NCT05253170 on ClinicalTrials.gov