Actively Recruiting
Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction
Led by Fudan University · Updated on 2024-11-25
80
Participants Needed
6
Research Sites
266 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
H
Huashan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically proven invasive breast cancer
- Clinical stage T0-3, T4b and N0-3a disease requiring neoadjuvant chemotherapy
- No distant metastasis
- Suitable for adjuvant radiotherapy and DIEP flap reconstruction at time of mastectomy
You will not qualify if you...
- Participation in other clinical trials that could affect outcomes
- Received neoadjuvant therapy without indication for radiotherapy
- Disease progression during neoadjuvant chemotherapy
- Pregnancy or lactation
- Previous history of diabetes
- Previous history of heavy smoking
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Guangxi Provincial Cancer Hospital
Nanning, Guangxi, China, 530021
Actively Recruiting
2
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
3
Hunan Provincial Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
4
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
5
Yunnan Provincial Cancer Hospital
Kunming, Yunnan, China, 650118
Actively Recruiting
6
Zhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
Research Team
J
Jiong Wu
CONTACT
S
Shuang Hao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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