Clinical trial NCT05512286: Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: DIEP flap
radiotherapy
breast cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
name: Hunan Cancer Hospital
name: Cancer Hospital of Guangxi Medical University
name: Yunnan Cancer Hospital
name: Zhejiang Cancer Hospital
name: Henan Cancer Hospital
First posted: 2022-08-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients enrolled in other clinical trial which may as influence the outcome;
* Patients received neoadjuvant therapy without radiotherapy indications；
* Disease progression during neoadjuvant chemotherapy；
* Patients of pregnancy or lactation；
* Previous history of diabetes；
* Previous history of heavy smoking.

Primary outcomes:
measure: Patient satisfaction with breasts questionnaire Patient satisfaction of breast
timeFrame: 24 months after surgery
Secondary outcomes:
measure: Complications of surgery
timeFrame: 3 months, 12 months, and 24 months
measure: Complications of radiotherapy
timeFrame: 3 months, 12 months, and 24 months after radiotherapy
measure: Failure rate of breast reconstruction surgery
timeFrame: 8 weeks after surgery
measure: Patient satisfaction with outcome questionnaire
timeFrame: 3months, 12 months, and 24 months after surgery
measure: Aesthetic evaluation
timeFrame: 12 months and 24 months after surgery
measure: Total pathologic complete response (tpCR)
timeFrame: up to 4 weeks after surgery
measure: 3-year disease free survival (DFS)
timeFrame: 3 years after diagnosis
Other outcomes:
Locations:
city: Nanning
country: China
facility: Guangxi Provincial Cancer Hospital
state: Guangxi
city: Zhengzhou
country: China
facility: Henan Provincial Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Provincial Cancer Hospital
state: Hunan
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
state: Shanghai
city: Kunming
country: China
facility: Yunnan Provincial Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Fudan University
name: Jiong Wu
role: PRINCIPAL_INVESTIGATOR
References: