Comparison of Patient-Reported Outcome and Safety Outcomes Between Preoperative and Postmastectomy Radiotherapy in Breast Cancer Patients with Reconstruction of DIEP Flap: a Multicenter,Prospective,Open-label,Randomized Controlled Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with histological proven invasive breast cancer;

• Clinical T0-3, T4b and N0-3a disease who require neoadjuvant chemotherapy;

• No distant metastasis;

• Adjuvant radiotherapy and who are suitable for DIEP flap reconstruction at the time of mastectomy.

Locations
Other Locations
China
Hunan Provincial Cancer Hospital
RECRUITING
Changsha
Zhejiang Provincial Cancer Hospital
RECRUITING
Hangzhou
Yunnan Provincial Cancer Hospital
RECRUITING
Kunming
Guangxi Provincial Cancer Hospital
RECRUITING
Nanning
Huashan Hospital of Fudan University
RECRUITING
Shanghai
Henan Provincial Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Jiong Wu
wujiong1122@vip.sina.com
862164175590
Backup
Shuang Hao
hzz50@hotmail.co,
862164175590
Time Frame
Start Date: 2022-08-25
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 80
Treatments
Experimental: Preoperative radiotherapy
Radiotherapy followed by mastectomy and DIEP flap reconstruction
Active_comparator: Postmastectomy radiotherapy
Radiotherapy after mastectomy and DIEP flap reconstruction
Related Therapeutic Areas
Sponsors
Collaborators: Hunan Cancer Hospital, Cancer Hospital of Guangxi Medical University, Zhejiang Cancer Hospital, Yunnan Cancer Hospital, Henan Cancer Hospital, Huashan Hospital
Leads: Fudan University

This content was sourced from clinicaltrials.gov