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

NCT05045287 | Unknown

• 1 other identifier: JS2021-6-1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Carcinoma

Keywords

hypofractionated radiotherapy; Two-Stage Expander/Implant Reconstruction; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• cosmetic result

  12 months after the reconstructive surgery

Other Outcomes (1)

• Acute and late radiotherapy toxicity

  through study completion, an average of 1 year

Study Arms (1)

hypofractionated radiation therapy

EXPERIMENTAL

receive chest wall and nodal irradiation at a dose of 43.5 Gy in 15 fractions over 3 weeks

Radiation: hypofractionated radiotherapy

Interventions

hypofractionated radiotherapy RADIATION

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

hypofractionated radiation therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Jiawei Lu

Shenzhen, Guangdong, 518116, China

RECRUITING

Related Publications (4)

• 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. 2017 Jun 20;35(18):2037-2043. doi: 10.1200/JCO.2016.70.7158. Epub 2017 May 1.

  PMID: 28459606 RESULT

• 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. Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):634-41. doi: 10.1016/j.ijrobp.2015.02.031. Epub 2015 Apr 28.

  PMID: 25936815 RESULT

• 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 high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30.

  PMID: 30711522 RESULT

• 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):761-769. doi: 10.1097/PRS.0000000000002534.

  PMID: 27673513 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Jing jin, MD

  Director of radiotherapy department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 16, 2021
• Study Start: April 8, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)