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

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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05512286

Acronym

CAPPELLA

Enrollment

Registered

2022-08-23

Start date

2022-08-25

Completion date

2027-10-01

Last updated

2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

DIEP flap, radiotherapy, breast cancer

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.

Interventions

RADIATIONPreoperative radiotherapy

Radiotherapy followed by mastectomy and DIEP flap reconstruction

RADIATIONPostmastectomy radiotherapy

Radiotherapy after mastectomy and DIEP flap reconstruction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Patient satisfaction with breasts questionnaire Patient satisfaction of breast	24 months after surgery	Patient satisfaction with breasts (as measured using the BREAST-Q reconstruction module) 24 months after surgery.

Secondary

Measure	Time frame	Description
Complications of radiotherapy	3 months, 12 months, and 24 months after radiotherapy	Complications of radiotherapy
Failure rate of breast reconstruction surgery	8 weeks after surgery	Failure rate of breast reconstruction surgery
Patient satisfaction with outcome questionnaire	3months, 12 months, and 24 months after surgery	Patient satisfaction with outcome (as measured using the BREAST-Q reconstruction module) 3months, 12 months, and 24 months after surgery
Complications of surgery	3 months, 12 months, and 24 months	Complications of surgery
Total pathologic complete response (tpCR)	up to 4 weeks after surgery	pathologic complete response of breast and lymph nodes
3-year disease free survival (DFS)	3 years after diagnosis	Oncological safety
Aesthetic evaluation	12 months and 24 months after surgery	Aesthetic evaluation (as measured using the Harris Score) 12 months and 24months after surgery. Breast aesthetic evaluation will subjectively be evaluated by two experts who applied the Harris score giving a mark of 1-4 for a poor to excellent result.

Countries

China

Contacts

Primary ContactJiong Wu

wujiong1122@vip.sina.com862164175590

Backup ContactShuang Hao

hzz50@hotmail.co,862164175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026