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

Breast Carcinoma Clinical Trial

Official title:

Phase II Study of Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045287
• Other study ID #: JS2021-6-1
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: September 2021
• Source: Chinese Academy of Medical Sciences
• Contact: Ning Li, MD
• Phone: 010-8778-8221
• Email: lining[@]cicams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Radiation:
• hypofractionated radiotherapy
Undergo hypofractionated RT,obeserve reconstruction failure,cosmetic result and recurrence rate

Locations

Country	Name	City	State
China	Jiawei Lu	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (4)

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

Outcome

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