Breast CancerCAPPELLANCT05512286
Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction
A study testing Preoperative radiotherapy and Postmastectomy radiotherapy in people with Breast Cancer, run by Fudan University at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Preoperative radiotherapy and Postmastectomy radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesChina
- Study dates
- 25 Aug 2022to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Hunan Provincial Cancer Hospital
Changsha, Hunan, 410031
Zan Li
Dajiang Song
- Recruiting
Zhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang, 310005
Yang Yu
Jiejie Hu
- Recruiting
Yunnan Provincial Cancer Hospital
Kunming, Yunnan, 650118
Dedian Chen
Sheng Huang
- Recruiting
Guangxi Provincial Cancer Hospital
Nanning, Guangxi, 530021
Huawei Yang
Xiaoming Liao
- Recruiting
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040
Qiang Zou
Yiting Jin
- Recruiting
Henan Provincial Cancer Hospital
Zhengzhou, Henan, 450003
Xuhui Guo
Zhenzhen Liu
About this study
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
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
- Breast Cancer
- Being tested
- Preoperative radiotherapy, Postmastectomy radiotherapy
- Keywords
- DIEP flap, radiotherapy, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative radiotherapyRadiation
Radiotherapy followed by mastectomy and DIEP flap reconstruction
Postmastectomy radiotherapyRadiation
Radiotherapy after mastectomy and DIEP flap reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Preoperative radiotherapy | Experimental | Radiotherapy followed by mastectomy and DIEP flap reconstruction Receives: Radiation: Preoperative radiotherapy |
| Postmastectomy radiotherapy | Active comparator | Radiotherapy after mastectomy and DIEP flap reconstruction Receives: Radiation: Postmastectomy radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after surgery
Secondary outcomes (7)
Complications of surgery
Complications of surgery
Measured: 3 months, 12 months, and 24 months
Complications of radiotherapy
Complications of radiotherapy
Measured: 3 months, 12 months, and 24 months after radiotherapy
Failure rate of breast reconstruction surgery
Failure rate of breast reconstruction surgery
Measured: 8 weeks after 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
Measured: 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.
Measured: 12 months and 24 months after surgery
Total pathologic complete response (tpCR)
pathologic complete response of breast and lymph nodes
Measured: up to 4 weeks after surgery
3-year disease free survival (DFS)
Oncological safety
Measured: 3 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start25 Aug 2022
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, Hunan Cancer Hospital, Cancer Hospital of Guangxi Medical University, Yunnan Cancer Hospital, Zhejiang Cancer Hospital, Henan Cancer Hospital
- Responsible party
- Principal investigator, Jiong Wu, Fudan University
- Investigators
- Jiong Wu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512286
- Sponsor's protocol ID
- CBCSG041
- Acronym
- CAPPELLA
- Status last verified
- Nov 2024
- First submitted
- 19 Aug 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39832996
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05512286
- Acronym / sponsor ID
- CAPPELLA / CBCSG041
- Conditions
- Breast Cancer
- Keywords
- DIEP flap, radiotherapy, breast cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Huashan Hospital, Hunan Cancer Hospital, Cancer Hospital of Guangxi Medical University, Yunnan Cancer Hospital, Zhejiang Cancer Hospital, Henan Cancer Hospital
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative radiotherapy | Experimental | Radiation: Preoperative radiotherapyRadiotherapy followed by mastectomy and DIEP flap reconstruction |
| Postmastectomy radiotherapy | Active comparator | Radiation: Postmastectomy radiotherapyRadiotherapy after mastectomy and DIEP flap reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative radiotherapyRadiotherapy followed by mastectomy and DIEP flap reconstruction | Radiation | Preoperative radiotherapy |
| Postmastectomy radiotherapyRadiotherapy after mastectomy and DIEP flap reconstruction | Radiation | Postmastectomy radiotherapy |
Primary outcome
Patient satisfaction with breasts questionnaire Patient satisfaction of breast
Time frame: 24 months after surgery
Patient satisfaction with breasts (as measured using the BREAST-Q reconstruction module) 24 months after surgery.
7 secondary outcomes
Complications of surgery
Time frame: 3 months, 12 months, and 24 months
Complications of radiotherapy
Time frame: 3 months, 12 months, and 24 months after radiotherapy
Failure rate of breast reconstruction surgery
Time frame: 8 weeks after surgery
Patient satisfaction with outcome questionnaire
Time frame: 3months, 12 months, and 24 months after surgery
Aesthetic evaluation
Time frame: 12 months and 24 months after surgery
Total pathologic complete response (tpCR)
Time frame: up to 4 weeks after surgery
3-year disease free survival (DFS)
Time frame: 3 years after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 39832996Hao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiong Wu principal investigator
Fudan University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative radiotherapy and Postmastectomy radiotherapy in people with Breast Cancer, run by Fudan University at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiong Wu (862164175590, wujiong1122@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with breasts questionnaire Patient satisfaction of breast (time frame: 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05512286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.