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NCT Number: NCT05512286

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Guangxi Provincial Cancer Hospital, Nanning, Guangxi, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

preoperative radiotherapy

Radiation

Radiotherapy followed by mastectomy and DIEP flap reconstruction

Postmastectomy radiotherapy

Radiation

Radiotherapy after mastectomy and DIEP flap reconstruction

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complications of surgery

    Time frame: 3 months, 12 months, and 24 months

    Complications of surgery

  2. Complications of radiotherapy

    Time frame: 3 months, 12 months, and 24 months after radiotherapy

    Complications of radiotherapy

  3. Failure rate of breast reconstruction surgery

    Time frame: 8 weeks after surgery

    Failure rate of breast reconstruction surgery

  4. Patient satisfaction with outcome questionnaire

    Time frame: 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

    Time frame: 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)

    Time frame: up to 4 weeks after surgery

    pathologic complete response of breast and lymph nodes

  7. 3-year disease free survival (DFS)

    Time frame: 3 years after diagnosis

    Oncological safety

Study contacts

Contact information is provided by the study sponsor or research team.

Jiong Wu

CONTACT

[email protected]

862164175590

Shuang Hao

CONTACT

[email protected],

862164175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

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

Registry information

Official study 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

Acronym: CAPPELLA

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 23, 2022
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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