Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients

NCT ID: NCT05253170

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 622 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2032-12-31

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.

Conditions

Breast Cancer; Radiotherapy; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hypofractionation

Intervention Type: RADIATION

Radiation regimen of 2.5-3.0Gy x 13-17 fractions +/- sequential boost 0-7 fractions

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.

Group Type: ACTIVE_COMPARATOR

Conventional Fractionation

Intervention Type: RADIATION

Radiation regimen of 1.8-2.0Gy x 23-28 fractions +/- sequential boost 0-5 fractions

Interventions

Hypofractionation

Radiation regimen of 2.5-3.0Gy x 13-17 fractions +/- sequential boost 0-7 fractions

Intervention Type: RADIATION

Conventional Fractionation

Radiation regimen of 1.8-2.0Gy x 23-28 fractions +/- sequential boost 0-5 fractions

Intervention Type: RADIATION

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

In Ah Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In Ah Kim, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Central Contacts

In Ah Kim, MD. PhD.

Role: CONTACT

inah228@snu.ac.kr

31-787-7651 ext. +82

Other Identifiers

KROG 21-07

Identifier Type: -

Identifier Source: org_study_id