Clinical Trials Logo
  1. Home
  2. Breast Cancer
  3. NCT05253170

Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients

Breast Cancer Clinical Trial

Official title:
A Randomized Phase III Trial of Hypofractionated Versus Conventionally Fractionated Radiotherapy in Breast Cancer Patients With Reconstruction After Mastectomy

Clinical Trial 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.

Clinical Trial Description

This study is a multicenter, randomized, phase 3 clinical trial. For breast cancer patients who underwent breast reconstruction after mastectomy, the hypofractionation radiotherapy group (experimental group) and the conventional fractionation radiotherapy group (control group) were divided 1:1 and compared to reveal the non-inferiority with hypofractionation in terms of major complication rate. I. Primary Objective - To show the non-inferiority of major complication rate in reconstructed-breast between the hypofractionation radiotherapy group (experimental group) and the conventional fractionation radiotherapy group (control group) at 2 years after radiation therapy. - The main complications are defined at those requiring hospitalization or surgery among complications. II. Secondary Objective: - Comparison of other side effects between the two groups. - Comparison of complication rate stratified by reconstruction timing and type of reconstruction - Immediate implant-based reconstruction - Immediate autologous reconstruction - Delayed-immediate implant reconstruction (2-stage) - Comparison of quality of life between the two groups. - Comparison of local and regional control rates between the two groups. III. Tertiary Objective: - Comparison of cosmetic evaluations between the two groups. - Dosimetry analysis for correlation between the occurrence of complications and the dose profile. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05253170
Study type Interventional
Source Seoul National University Bundang Hospital
Contact In Ah Kim, MD. PhD.
Phone 31-787-7651
Email inah228@snu.ac.kr
Status Not yet recruiting
Phase Phase 3
Start date April 1, 2022
Completion date December 31, 2032
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Recruiting NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A