Clinical trial · Interventional
Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients
A Randomized Phase III Trial of Hypofractionated Versus Conventionally Fractionated Radiotherapy in Breast Cancer Patients With Reconstruction After Mastectomy
NCT05253170CI-TRIAL-00057073not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy; Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Fractionation | Radiation | — | UNRESOLVED |
| Hypofractionation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypofractionation
- 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.
- interventionNames
- Radiation: Hypofractionation
- type
- ACTIVE_COMPARATOR
- label
- Conventional Fractionation
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.