search
Back to results

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

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Preoperative radiotherapy
Postmastectomy radiotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring DIEP flap, radiotherapy, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preoperative radiotherapy

Postmastectomy radiotherapy

Arm Description

Radiotherapy followed by mastectomy and DIEP flap reconstruction

Radiotherapy after mastectomy and DIEP flap reconstruction

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complications of surgery
Complications of surgery
Complications of radiotherapy
Complications of radiotherapy
Failure rate of breast reconstruction surgery
Failure rate of breast reconstruction surgery
Patient satisfaction with outcome questionnaire
Patient satisfaction with outcome (as measured using the BREAST-Q reconstruction module) 3months, 12 months, and 24 months after surgery
Aesthetic evaluation
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.
Total pathologic complete response (tpCR)
pathologic complete response of breast and lymph nodes
3-year disease free survival (DFS)
Oncological safety

Full Information

First Posted
August 19, 2022
Last Updated
August 22, 2022
Sponsor
Fudan University
Collaborators
Huashan Hospital, Hunan Cancer Hospital, Cancer Hospital of Guangxi Medical University, Yunnan Cancer Hospital, Zhejiang Cancer Hospital, Henan Cancer Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05512286
Brief Title
Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction
Acronym
CAPPELLA
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2026 (Anticipated)
Study Completion Date
October 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Huashan Hospital, Hunan Cancer Hospital, Cancer Hospital of Guangxi Medical University, Yunnan Cancer Hospital, Zhejiang Cancer Hospital, Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
DIEP flap, radiotherapy, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative radiotherapy
Arm Type
Experimental
Arm Description
Radiotherapy followed by mastectomy and DIEP flap reconstruction
Arm Title
Postmastectomy radiotherapy
Arm Type
Active Comparator
Arm Description
Radiotherapy after mastectomy and DIEP flap reconstruction
Intervention Type
Radiation
Intervention Name(s)
Preoperative radiotherapy
Intervention Description
Radiotherapy followed by mastectomy and DIEP flap reconstruction
Intervention Type
Radiation
Intervention Name(s)
Postmastectomy radiotherapy
Intervention Description
Radiotherapy after mastectomy and DIEP flap reconstruction
Primary Outcome Measure Information:
Title
Patient satisfaction with breasts questionnaire Patient satisfaction of breast
Description
Patient satisfaction with breasts (as measured using the BREAST-Q reconstruction module) 24 months after surgery.
Time Frame
24 months after surgery
Secondary Outcome Measure Information:
Title
Complications of surgery
Description
Complications of surgery
Time Frame
3 months, 12 months, and 24 months
Title
Complications of radiotherapy
Description
Complications of radiotherapy
Time Frame
3 months, 12 months, and 24 months after radiotherapy
Title
Failure rate of breast reconstruction surgery
Description
Failure rate of breast reconstruction surgery
Time Frame
8 weeks after surgery
Title
Patient satisfaction with outcome questionnaire
Description
Patient satisfaction with outcome (as measured using the BREAST-Q reconstruction module) 3months, 12 months, and 24 months after surgery
Time Frame
3months, 12 months, and 24 months after surgery
Title
Aesthetic evaluation
Description
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.
Time Frame
12 months and 24 months after surgery
Title
Total pathologic complete response (tpCR)
Description
pathologic complete response of breast and lymph nodes
Time Frame
up to 4 weeks after surgery
Title
3-year disease free survival (DFS)
Description
Oncological safety
Time Frame
3 years after diagnosis

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiong Wu
Phone
862164175590
Email
wujiong1122@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shuang Hao
Phone
862164175590
Email
hzz50@hotmail.co,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiong Wu
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangxi Provincial Cancer Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Henan Provincial Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Hunan Provincial Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410031
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zan Li
First Name & Middle Initial & Last Name & Degree
Dajiang Song
Facility Name
Huashan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Zou
First Name & Middle Initial & Last Name & Degree
Yiting Jin
Facility Name
Yunnan Provincial Cancer Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Facility Name
Zhejiang Provincial Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs