Clinical trial · Interventional
Adjuvant Ultra-Hypofractionated vs Hypofractionated Radiotherapy for Early Breast Cancer
Adjuvant Ultra Hypofractionation Radiotherapy Versus Hypofractionation Radiotherapy in Treatment of Early Invasive Breast Cancer
- 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)
breast-conserving surgery. One group receives ultra-hypofractionated radiotherapy (26 Gy in 5 sessions over 1 week), while the other group receives hypofractionated radiotherapy (40 Gy in 15 sessions over 3 weeks). The study aims to compare skin toxicity, cosmetic outcomes, and local cancer control between thetwo schedules . Participants are followed during and after radiotherapy for up to 24 months.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Hypofarctionated radiotherapy | Radiation | — | UNRESOLVED |
| Adjuvant Ultra hypofractionation radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A:Adjuvat Ultra-Hypofractionation Radiotherapy
- description
- Adjuvant external beam radiotherapy after breast-conserving surgery Total dose: 26 Gy delivered in 5 fractions over 1 week 3D conformal radiotherapy technique without breath-hold Daily fractionation, whole breast irradiation
- interventionNames
- Radiation: Adjuvant Ultra hypofractionation radiotherapy
- type
- EXPERIMENTAL
- label
- Arm B: Adjuvant hypofractionation radiotherapy
- interventionNames
- Radiation: Adjuvant Hypofarctionated radiotherapy
Primary outcomes (1)
- measure
- Acute Skin Toxicity (CTCAE v5.0)
- timeFrame
- From start of radiotherapy to 6 weeks post-treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:• Histological diagnosis of breast adenocarcinoma * Prior breast conservative surgery negative resection margins (3 mm) * Pathological stage pT1-pT2, N0-1, pT3-N0, M0 * No macroscopic evidence of distant metastases at diagnosis * Age 18-80 years * Female patients * Normal hematological and biochemical laboratory tests * Written informed consent was obtained from all patients Exclusion Criteria: • Patients underwent mastectomy. * Locally advanced disease pT4, N2,3. * Positive surgical margins * Prior thoracic radiation * Synchronous second primary tumor * Distant metastases * Pregnancy * Presence of a concomitant psychiatric disorder precluding an aware informed consent. * Age \>80 years * Low risk patient meeting all the following criteria (more than or equal 65 years, PT1, grade 1 or 2, +ER, -Her2nu, N0, M0).
References
Publications (0)
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