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Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction

NCT05512286 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-11-25

No results posted yet for this study

Summary

This study is the first prospective randomized study assessing the patient-reported outcomes and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction of deep inferior epigastric perforator(DIEP) flap. Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. We aimed to explore the feasibility of preoperative radiotherapy followed by DIEP flap reconstruction in patients with breast cancer requiring mastectomy.

Conditions

Interventions

RADIATION

Preoperative radiotherapy

Radiotherapy followed by mastectomy and DIEP flap reconstruction

RADIATION

Postmastectomy radiotherapy

Radiotherapy after mastectomy and DIEP flap reconstruction

Sponsors & Collaborators

  • Huashan Hospital

    collaborator OTHER

  • Hunan Cancer Hospital

    collaborator OTHER

  • Cancer Hospital of Guangxi Medical University

    collaborator OTHER

  • Yunnan Cancer Hospital

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • Fudan University

    lead OTHER

Principal Investigators

  • Jiong Wu · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-25
Primary Completion
2026-07-01
Completion
2027-10-01

Countries

  • China

Study Locations

More Related Trials

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 NCT05512286 on ClinicalTrials.gov