Breast Carcinoma Clinical Trial
Official title:
Phase II Study of Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction
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.
Status | Recruiting |
Enrollment | 57 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Jiawei Lu | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences |
China,
Fowble B, Park C, Wang F, Peled A, Alvarado M, Ewing C, Esserman L, Foster R, Sbitany H, Hanlon A. Rates of Reconstruction Failure in Patients Undergoing Immediate Reconstruction With Tissue Expanders and/or Implants and Postmastectomy Radiation Therapy. — View Citation
Khan AJ, Poppe MM, Goyal S, Kokeny KE, Kearney T, Kirstein L, Toppmeyer D, Moore DF, Chen C, Gaffney DK, Haffty BG. Hypofractionated Postmastectomy Radiation Therapy Is Safe and Effective: First Results From a Prospective Phase II Trial. J Clin Oncol. 201 — View Citation
Santosa KB, Chen X, Qi J, Ballard TNS, Kim HM, Hamill JB, Bensenhaver JM, Pusic AL, Wilkins EG. Postmastectomy Radiation Therapy and Two-Stage Implant-Based Breast Reconstruction: Is There a Better Time to Irradiate? Plast Reconstr Surg. 2016 Oct;138(4):7 — View Citation
Wang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acute and late radiotherapy toxicity | Radiotherapy toxicity assessed by CTCAE3 and RTOG standard (e. g. acute skin toxicity, radiation pneumo nitis, etc.) | through study completion, an average of 1 year | |
Primary | 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.) | 12 months after the reconstructive surgery | |
Secondary | 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). | 12 months after the reconstructive surgery |
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