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Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients

ConditionsBreast Cancer Radiotherapy; Complications

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexFemale

Age19-85

SponsorSeoul National University Bundang Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Hypofractionation
Radiation
Radiation regimen of 2.5-3.0Gy x 13-17 fractions +/- sequential boost 0-7 fractions
Conventional Fractionation
Radiation
Radiation regimen of 1.8-2.0Gy x 23-28 fractions +/- sequential boost 0-5 fractions

Treatment groups

622 Participants

are divided into 2 treatment groups

Group A: HypofractionationExperimental treatment 1 intervention

Group B: Conventional FractionationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major Complication Rate

* 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

2

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

Time frame

Up to 2 years after the completion of radiation therapy

Secondary outcomes

1

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

Time frame

Up to 2 years after the completion of radiation therapy

2

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

Time frame

Up to 2 years after the completion of radiation therapy

3

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

Time frame

Up to 2 years after the completion of radiation therapy

4

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

Time frame

Up to 2 years after the completion of radiation therapy

Other outcomes

1

Arm Lymphedema [Optional]

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

2

Cosmetic Outcome [Optional]

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Bundang Hospital

Lead sponsor

Seoul National University Hospital

Collaborator

Source ClinicalTrials.gov

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