Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction

Chinese Academy of Medical Sciences57 enrolled

Overview

Hypofractionated radiotherapy could provide more convenient treatment and had similar toxicities.However,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare,Some studies have shown that hypofractionated radiotherapy had similar toxicities to conventional fractionated radiotherapy in patients with breast reconstruction. So,investigators conducted a phase II study to observe the reconstruction failure in hypofractionated radiotherapy with two-stage expander/implant reconstruction.

Results from a phase III randomized controlled study in China showed that Postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer.However,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare. Literatures report that reconstruction failure is a well-known complication of radiation therapy in breast cancer patients with reconstruction. Results may vary based on RT timing and technique. Some studies have shown that hypofractionated radiotherapy had similar reconstruction failure to conventional fractionated radiotherapy in patients with breast reconstruction. So,investigators conducted a phase II study to observe the reconstruction failure in hypofractionated radiotherapy with two-stage expander/implant reconstruction.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Carcinoma

Interventions

hypofractionated radiotherapyRADIATION

Undergo hypofractionated RT，obeserve reconstruction failure，cosmetic result and recurrence rate

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologic diagnosis of stage I-IIIc invasive breast cancer (ductal, lobular, mammary, medullary, or ductal) ≤ T3 or N+ * negative surgery margins * positive postoperative pathologic axillary lymph nodes after neoadjuvant chemotherapy (ypN+). * Undergo mastectomy+expander+RT（hypofractionated radiotherapy）+delayed prosthesis reconstruction * Sign the informed consent form Exclusion Criteria: * T4, * axillary sentinel lymph node biopsy without axillary dissection * Recurrent breast cancer or history of prior breast radiation therapy (neck, chest wall, axilla) * Uncontrollable co-morbidities, including but not limited to active collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis), persistent or active infection, symptomatic congestive heart failure, unstable angina, mental illness incapacitating participation in this study * Pregnancy or breastfeeding * History of malignancy other than the following： (At least 5 years of tumor free survival with a very low risk of recurrence, e.g., carcinoma in situ of the cervix and basal cell or squamous cell carcinoma of the skin） * requiring bilateral breast/chest wall radiation therapy

Locations (1)

Jiawei Lu

Shenzhen, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

reconstruction failure

the 1-year rate of implant removal due to serious complications (such as infection, hematoma, seromatas, prosthesis exposure, prosthesis rupture, envelope contracture, severe breast deformity, etc.)

Time frame: 12 months after the reconstructive surgery

Secondary Outcomes

cosmetic result

Digital photographs will be taken of each patient to facilitate thorough assessment of breast symmetry, cleavage and donor site scarring. Overall satisfaction is scored on a five-point Likert scale (1 = very unhappy, 5 = very happy).

Time frame: 12 months after the reconstructive surgery

Central Contacts

Ning Li, MD

CONTACT

010-8778-8221 lining@cicams.ac.cn

Data from ClinicalTrials.gov

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