Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients

NCT05253170 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: KROG 21-07
• Study Type: interventional
• Target: 622
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Radiotherapy; Complications

Keywords

Mastectomy; Reconstruction; Radiation therapy; Conventional fractionation; Hypofractionation; Complication

Outcome Measures

Primary Outcomes (2)

• Major Complication Rate

  * Unplanned re-hospitalization or re-operation for intervention * Implant removal due to infection, autologous flap total failure (reconstruction failure)

  Up to 2 years after the completion of radiation therapy

• 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

  Up to 2 years after the completion of radiation therapy

Secondary Outcomes (4)

• Hematoma

  Up to 2 years after the completion of radiation therapy

• Wound infection

  Up to 2 years after the completion of radiation therapy

• Wound Dehiscence

  Up to 2 years after the completion of radiation therapy

• Seroma

  Up to 2 years after the completion of radiation therapy

Other Outcomes (2)

• Arm Lymphedema [Optional]

  Up to 2 years after the completion of radiation therapy

• Cosmetic Outcome [Optional]

  Up to 2 years after the completion of radiation therapy

Study Arms (2)

Hypofractionation

EXPERIMENTAL

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.

Radiation: Hypofractionation

Conventional Fractionation

ACTIVE COMPARATOR

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.

Radiation: Conventional Fractionation

Interventions

Hypofractionation RADIATION

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

Hypofractionation

Conventional Fractionation RADIATION

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

Conventional Fractionation

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Seoul National University Hospital: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• In Ah Kim, MD. PhD.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

In Ah Kim, MD. PhD.

CONTACT

31-787-7651; inah228@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 23, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share