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Trial Title:
Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction
NCT ID:
NCT05512286
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
DIEP flap
radiotherapy
breast cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Preoperative radiotherapy
Description:
Radiotherapy followed by mastectomy and DIEP flap reconstruction
Arm group label:
Preoperative radiotherapy
Intervention type:
Radiation
Intervention name:
Postmastectomy radiotherapy
Description:
Radiotherapy after mastectomy and DIEP flap reconstruction
Arm group label:
Postmastectomy radiotherapy
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangxi Provincial Cancer Hospital
Address:
City:
Nanning
Zip:
530021
Country:
China
Facility:
Name:
Henan Provincial Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Facility:
Name:
Hunan Provincial Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Contact:
Last name:
Zan Li
Contact backup:
Last name:
Dajiang Song
Facility:
Name:
Huashan Hospital of Fudan University
Address:
City:
Shanghai
Zip:
200040
Country:
China
Contact:
Last name:
Qiang Zou
Contact backup:
Last name:
Yiting Jin
Facility:
Name:
Yunnan Provincial Cancer Hospital
Address:
City:
Kunming
Zip:
650118
Country:
China
Facility:
Name:
Zhejiang Provincial Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Start date:
September 1, 2022
Completion date:
October 1, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Huashan Hospital
Agency class:
Other
Collaborator:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Cancer Hospital of Guangxi Medical University
Agency class:
Other
Collaborator:
Agency:
Yunnan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512286
