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

• Sponsor: Fudan University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05512286
• Collaborator: 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)
• Enrollment: 80
• Locations: 6
• Arms: 2
• Anticipated Duration (Months): 61
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Radiation: Preoperative radiotherapy; Radiation: Postmastectomy radiotherapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2026
• Anticipated Study Completion Date: Oct 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Preoperative radiotherapy Radiotherapy followed by mastectomy and DIEP flap reconstruction	Radiation: Preoperative radiotherapy; Radiotherapy followed by mastectomy and DIEP flap reconstruction
Active Comparator: Postmastectomy radiotherapy Radiotherapy after mastectomy and DIEP flap reconstruction	Radiation: Postmastectomy radiotherapy; Radiotherapy after mastectomy and DIEP flap reconstruction

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Complications of surgery [3 months, 12 months, and 24 months]

   Complications of surgery

2. Complications of radiotherapy [3 months, 12 months, and 24 months after radiotherapy]

   Complications of radiotherapy

3. Failure rate of breast reconstruction surgery [8 weeks after surgery]

   Failure rate of breast reconstruction surgery

4. 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

5. 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.

6. Total pathologic complete response (tpCR) [up to 4 weeks after surgery]

   pathologic complete response of breast and lymph nodes

7. 3-year disease free survival (DFS) [3 years after diagnosis]

   Oncological safety

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangxi Provincial Cancer Hospital	Nanning	Guangxi	China	530021
2	Henan Provincial Cancer Hospital	Zhengzhou	Henan	China	450003
3	Hunan Provincial Cancer Hospital	Changsha	Hunan	China	410031
4	Huashan Hospital of Fudan University	Shanghai	Shanghai	China	200040
5	Yunnan Provincial Cancer Hospital	Kunming	Yunnan	China	650118
6	Zhejiang Provincial Cancer Hospital	Hangzhou	Zhejiang	China	310005

Sponsors and Collaborators

• Fudan University
• Huashan Hospital
• Hunan Cancer Hospital
• Cancer Hospital of Guangxi Medical University
• Yunnan Cancer Hospital
• Zhejiang Cancer Hospital
• Henan Cancer Hospital

Investigators

• Principal Investigator: Jiong Wu, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiong Wu, Professor, Fudan University
• ClinicalTrials.gov Identifier: NCT05512286
• Other Study ID Numbers: CBCSG041
• First Posted: Aug 23, 2022
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jiong Wu, Professor, Fudan University: DIEP flap; radiotherapy; breast cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Aug 23, 2022