A Randomized Phase III Trial of Hypofractionated Versus Conventionally Fractionated Radiotherapy in Breast Cancer Patients With Reconstruction After Mastectomy
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 622
- Primary Endpoint
- Major Complication Rate
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 85 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Hypofractionation
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.
Intervention: Hypofractionation (Radiation)
Conventional Fractionation
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: Conventional Fractionation (Radiation)
Outcomes
Primary Outcomes
Major Complication Rate
Time Frame: Up to 2 years after the completion of radiation therapy
* 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)
Time Frame: Up to 2 years after the completion of radiation therapy
• 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 Outcomes
- Seroma(Up to 2 years after the completion of radiation therapy)
- Hematoma(Up to 2 years after the completion of radiation therapy)
- Wound Dehiscence(Up to 2 years after the completion of radiation therapy)
- Wound infection(Up to 2 years after the completion of radiation therapy)
Investigators
In Ah Kim
Professor
Seoul National University Bundang Hospital