Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Postmastectomy radiotherapy | Radiation | — | UNRESOLVED |
| Preoperative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Preoperative radiotherapy
- description
- Radiotherapy followed by mastectomy and DIEP flap reconstruction
- interventionNames
- Radiation: Preoperative radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Postmastectomy radiotherapy
- description
- Radiotherapy after mastectomy and DIEP flap reconstruction
- interventionNames
- Radiation: Postmastectomy radiotherapy
Primary outcomes (1)
- measure
- Patient satisfaction with breasts questionnaire Patient satisfaction of breast
- timeFrame
- 24 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHao S, Hou J, Zhang L, Zhou C, Hou Y, Yu K, Hu Z, Liu G, Di G, Shao ZM, Yu X, Wu J. Protocol for a multicentre, prospective, open-label, randomised controlled trial to compare PROs and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction via a deep inferior epigastric perforator flap (CAPPELLA) in China. BMJ Open. 2025 Jan 20;15(1):e086980. doi: 10.1136/bmjopen-2024-086980. PMID 39832996