Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction
NCT ID: NCT05512286
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2022-08-25
2027-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Preoperative radiotherapy
Radiotherapy followed by mastectomy and DIEP flap reconstruction
Preoperative radiotherapy
Radiotherapy followed by mastectomy and DIEP flap reconstruction
Postmastectomy radiotherapy
Radiotherapy after mastectomy and DIEP flap reconstruction
Postmastectomy radiotherapy
Radiotherapy after mastectomy and DIEP flap reconstruction
Interventions
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Preoperative radiotherapy
Radiotherapy followed by mastectomy and DIEP flap reconstruction
Postmastectomy radiotherapy
Radiotherapy after mastectomy and DIEP flap reconstruction
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Huashan Hospital
OTHER
Hunan Cancer Hospital
OTHER
Cancer Hospital of Guangxi Medical University
OTHER
Yunnan Cancer Hospital
OTHER
Zhejiang Cancer Hospital
OTHER
Henan Cancer Hospital
OTHER_GOV
Fudan University
OTHER
Responsible Party
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Jiong Wu
Professor
Principal Investigators
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Jiong Wu
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Guangxi Provincial Cancer Hospital
Nanning, Guangxi, China
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China
Hunan Provincial Cancer Hospital
Changsha, Hunan, China
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Yunnan Provincial Cancer Hospital
Kunming, Yunnan, China
Zhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Huawei Yang
Role: primary
Xiaoming Liao
Role: backup
Xuhui Guo
Role: primary
Zhenzhen Liu
Role: backup
Zan Li
Role: primary
Dajiang Song
Role: backup
Qiang Zou
Role: primary
Yiting Jin
Role: backup
Dedian Chen
Role: primary
Sheng Huang
Role: backup
Yang Yu
Role: primary
Jiejie Hu
Role: backup
References
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Hao 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.
Other Identifiers
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CBCSG041
Identifier Type: -
Identifier Source: org_study_id
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