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

Primary Purpose

Breast Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hypofractionated radiotherapy
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Carcinoma focused on measuring hypofractionated radiotherapy, Two-Stage Expander/Implant Reconstruction, breast cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jiawei LuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hypofractionated radiation therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

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).

Full Information

First Posted
August 24, 2021
Last Updated
September 6, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05045287
Brief Title
Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction
Official Title
Phase II Study of Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma
Keywords
hypofractionated radiotherapy, Two-Stage Expander/Implant Reconstruction, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hypofractionated radiation therapy
Arm Type
Experimental
Arm Description
receive chest wall and nodal irradiation at a dose of 43.5 Gy in 15 fractions over 3 weeks
Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiotherapy
Intervention Description
Undergo hypofractionated RT，obeserve reconstruction failure，cosmetic result and recurrence rate
Primary Outcome Measure Information:
Title
reconstruction failure
Description
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 Outcome Measure Information:
Title
cosmetic result
Description
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
Other Pre-specified Outcome Measures:
Title
Acute and late radiotherapy toxicity
Description
Radiotherapy toxicity assessed by CTCAE3 and RTOG standard （e. g. acute skin toxicity, radiation pneumo nitis, etc.)
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Li, MD
Phone
010-8778-8221
Email
lining@cicams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing jin, MD
Organizational Affiliation
Director of radiotherapy department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiawei Lu
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518116
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiawei Lu, MMed
Phone
15106203082
Email
ljw120920@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28459606
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. 2017 Jun 20;35(18):2037-2043. doi: 10.1200/JCO.2016.70.7158. Epub 2017 May 1.
Results Reference
result
PubMed Identifier
25936815
Citation
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.
Results Reference
result
PubMed Identifier
30711522
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 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.
Results Reference
result
PubMed Identifier
27673513
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):761-769. doi: 10.1097/PRS.0000000000002534.
Results Reference
result

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

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