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Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients

Primary Purpose

Breast Cancer, Radiotherapy; Complications

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hypofractionation
Conventional Fractionation
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Mastectomy, Reconstruction, Radiation therapy, Conventional fractionation, Hypofractionation, Complication

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female patient who underwent mastectomy for invasive breast cancer
  • Patients who have undergone breast reconstruction after mastectomy or who have inserted a tissue expander
  • (y)p patients with stage IIIA or lower (excluding T4 and N3 patients) who need adjuvant radiation therapy
  • Eastern Cooperative Oncology Group Performance ≤ 2
  • Age ≥ 19 years
  • Patients who agreed to participate in the study

Exclusion Criteria:

  • Patients who already had implants at the time of diagnosis of breast cancer or who have already undergone reconstructive surgery
  • Patients who underwent reconstruction after partial resection or breast conserving surgery rather than mastectomy
  • Patients who are using or planning to use an air expander
  • Patients receiving radiation therapy for salvage or palliative purposes
  • Patients with distant metastases at the time of diagnosis
  • Patients who are scheduled to undergo concurrent chemoradiation therapy
  • Patients with bilateral breast cancer
  • Male breast cancer patients
  • Patients who have previously received radiation therapy for the ipsilateral breast or supraclavicular area
  • Patients with history of cancers other than thyroid cancer, intraepithelial cancer of the cervix, or skin cancer
  • Patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or other benign tumors based on histological diagnosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hypofractionation

    Conventional Fractionation

    Arm Description

    For the cumulative total dose of 39-45.9 Gy to the chest wall, a daily dose of 2.5-3.0 Gy is administered 13-17 fractions. Should be started within 3 months of completion of mastectomy or chemotherapy. Clinical target volume (CTV) may include regional lymph nodes. If a tissue expander or implant is present at the time of radiotherapy planning, CTV contouring should be performed according to the ESTRO ACROP implant-based target delineation guidelines.

    For the cumulative total dose of 45-50.4 Gy to the chest wall, a daily dose of 1.8-2.0 Gy is administered 23-28 fractions. Should be started within 3 months of completion of mastectomy or chemotherapy. Clinical target volume (CTV) may include regional lymph nodes. If a tissue expander or implant is present at the time of radiotherapy planning, CTV contouring should be performed according to the ESTRO ACROP implant-based target delineation guidelines.

    Outcomes

    Primary Outcome Measures

    Major Complication Rate
    Unplanned re-hospitalization or re-operation for intervention Implant removal due to infection, autologous flap total failure (reconstruction failure)
    Capsular Contracture (If implant-based recontruction is performed)
    • Baker Scale G1: the breast is normally soft and appears natural in size and shape G2: the breast is a little firm, but appears normal G3: the breast is firm and appears abnormal G4: the breast is hard, painful to the touch, and appears abnormal

    Secondary Outcome Measures

    Hematoma
    NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0 G1: Mild symptoms; intervention not indicated G2: Minimally invasive evacuation or aspiration indicated G3: Transfusion; invasive intervention indicated G4: Life-threatening consequences; urgent intervention indicated G5: Death
    Wound infection
    NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0 G1: Localized, local intervention indicate G2: Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral) G3: IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated G4: Life-threatening consequences; urgent intervention indicated G5: Death
    Wound Dehiscence
    NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0 G1: Incisional separation, intervention not indicated G2: Incisional separation, local care (e.g., suturing) or medical intervention indicated (e.g., analgesic) G3: Fascial disruption or dehiscence without evisceration; revision by operative intervention indicated G4: Life-threatening consequences; symptomatic hernia with evidence of strangulation; fascial disruption with evisceration; major reconstruction flap, grafting, resection, or amputation indicated G5: Death
    Seroma
    NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0 G1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated G2: Symptomatic; simple aspiration indicated G3: Symptomatic, elective invasive intervention indicated

    Full Information

    First Posted
    February 15, 2022
    Last Updated
    February 23, 2022
    Sponsor
    Seoul National University Bundang Hospital
    Collaborators
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05253170
    Brief Title
    Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients
    Official Title
    A Randomized Phase III Trial of Hypofractionated Versus Conventionally Fractionated Radiotherapy in Breast Cancer Patients With Reconstruction After Mastectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2027 (Anticipated)
    Study Completion Date
    December 31, 2032 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Bundang Hospital
    Collaborators
    Seoul National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy and reconstruction surgery.
    Detailed Description
    This study is a multicenter, randomized, phase 3 clinical trial. For breast cancer patients who underwent breast reconstruction after mastectomy, the hypofractionation radiotherapy group (experimental group) and the conventional fractionation radiotherapy group (control group) were divided 1:1 and compared to reveal the non-inferiority with hypofractionation in terms of major complication rate. I. Primary Objective To show the non-inferiority of major complication rate in reconstructed-breast between the hypofractionation radiotherapy group (experimental group) and the conventional fractionation radiotherapy group (control group) at 2 years after radiation therapy. The main complications are defined at those requiring hospitalization or surgery among complications. II. Secondary Objective: Comparison of other side effects between the two groups. Comparison of complication rate stratified by reconstruction timing and type of reconstruction Immediate implant-based reconstruction Immediate autologous reconstruction Delayed-immediate implant reconstruction (2-stage) Comparison of quality of life between the two groups. Comparison of local and regional control rates between the two groups. III. Tertiary Objective: Comparison of cosmetic evaluations between the two groups. Dosimetry analysis for correlation between the occurrence of complications and the dose profile.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Radiotherapy; Complications
    Keywords
    Mastectomy, Reconstruction, Radiation therapy, Conventional fractionation, Hypofractionation, Complication

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    622 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypofractionation
    Arm Type
    Experimental
    Arm Description
    For the cumulative total dose of 39-45.9 Gy to the chest wall, a daily dose of 2.5-3.0 Gy is administered 13-17 fractions. Should be started within 3 months of completion of mastectomy or chemotherapy. Clinical target volume (CTV) may include regional lymph nodes. If a tissue expander or implant is present at the time of radiotherapy planning, CTV contouring should be performed according to the ESTRO ACROP implant-based target delineation guidelines.
    Arm Title
    Conventional Fractionation
    Arm Type
    Active Comparator
    Arm Description
    For the cumulative total dose of 45-50.4 Gy to the chest wall, a daily dose of 1.8-2.0 Gy is administered 23-28 fractions. Should be started within 3 months of completion of mastectomy or chemotherapy. Clinical target volume (CTV) may include regional lymph nodes. If a tissue expander or implant is present at the time of radiotherapy planning, CTV contouring should be performed according to the ESTRO ACROP implant-based target delineation guidelines.
    Intervention Type
    Radiation
    Intervention Name(s)
    Hypofractionation
    Intervention Description
    Radiation regimen of 2.5-3.0Gy x 13-17 fractions +/- sequential boost 0-7 fractions
    Intervention Type
    Radiation
    Intervention Name(s)
    Conventional Fractionation
    Intervention Description
    Radiation regimen of 1.8-2.0Gy x 23-28 fractions +/- sequential boost 0-5 fractions
    Primary Outcome Measure Information:
    Title
    Major Complication Rate
    Description
    Unplanned re-hospitalization or re-operation for intervention Implant removal due to infection, autologous flap total failure (reconstruction failure)
    Time Frame
    Up to 2 years after the completion of radiation therapy
    Title
    Capsular Contracture (If implant-based recontruction is performed)
    Description
    • Baker Scale G1: the breast is normally soft and appears natural in size and shape G2: the breast is a little firm, but appears normal G3: the breast is firm and appears abnormal G4: the breast is hard, painful to the touch, and appears abnormal
    Time Frame
    Up to 2 years after the completion of radiation therapy
    Secondary Outcome Measure Information:
    Title
    Hematoma
    Description
    NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0 G1: Mild symptoms; intervention not indicated G2: Minimally invasive evacuation or aspiration indicated G3: Transfusion; invasive intervention indicated G4: Life-threatening consequences; urgent intervention indicated G5: Death
    Time Frame
    Up to 2 years after the completion of radiation therapy
    Title
    Wound infection
    Description
    NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0 G1: Localized, local intervention indicate G2: Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral) G3: IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated G4: Life-threatening consequences; urgent intervention indicated G5: Death
    Time Frame
    Up to 2 years after the completion of radiation therapy
    Title
    Wound Dehiscence
    Description
    NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0 G1: Incisional separation, intervention not indicated G2: Incisional separation, local care (e.g., suturing) or medical intervention indicated (e.g., analgesic) G3: Fascial disruption or dehiscence without evisceration; revision by operative intervention indicated G4: Life-threatening consequences; symptomatic hernia with evidence of strangulation; fascial disruption with evisceration; major reconstruction flap, grafting, resection, or amputation indicated G5: Death
    Time Frame
    Up to 2 years after the completion of radiation therapy
    Title
    Seroma
    Description
    NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0 G1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated G2: Symptomatic; simple aspiration indicated G3: Symptomatic, elective invasive intervention indicated
    Time Frame
    Up to 2 years after the completion of radiation therapy
    Other Pre-specified Outcome Measures:
    Title
    Arm Lymphedema [Optional]
    Description
    In each follow-up time, arm circumference is measured at 10 cm above the ipsilateral and contralateral anterior cubital fossa. Lymphedema is considered to be occurred if a difference of ≥10% between two measures.
    Time Frame
    Up to 2 years after the completion of radiation therapy
    Title
    Cosmetic Outcome [Optional]
    Description
    Skin 3D reconstruction was performed based on the radiation therapy plan CT and breast CT at 24 months after radiotherapy. Using in-house software based on deep learning algorithm, cosmetic scores are produced and compared between groups.
    Time Frame
    Up to 2 years after the completion of radiation therapy

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female patient who underwent mastectomy for invasive breast cancer Patients who have undergone breast reconstruction after mastectomy or who have inserted a tissue expander (y)p patients with stage IIIA or lower (excluding T4 and N3 patients) who need adjuvant radiation therapy Eastern Cooperative Oncology Group Performance ≤ 2 Age ≥ 19 years Patients who agreed to participate in the study Exclusion Criteria: Patients who already had implants at the time of diagnosis of breast cancer or who have already undergone reconstructive surgery Patients who underwent reconstruction after partial resection or breast conserving surgery rather than mastectomy Patients who are using or planning to use an air expander Patients receiving radiation therapy for salvage or palliative purposes Patients with distant metastases at the time of diagnosis Patients who are scheduled to undergo concurrent chemoradiation therapy Patients with bilateral breast cancer Male breast cancer patients Patients who have previously received radiation therapy for the ipsilateral breast or supraclavicular area Patients with history of cancers other than thyroid cancer, intraepithelial cancer of the cervix, or skin cancer Patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or other benign tumors based on histological diagnosis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    In Ah Kim, MD. PhD.
    Phone
    31-787-7651
    Ext
    +82
    Email
    inah228@snu.ac.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    In Ah Kim, MD. PhD.
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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