Clinical trial · Interventional
Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer
Comparative Study Between Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer
NCT04434677CI-TRIAL-00051004unknownN/AClinicalTrials.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)
Prospective randomized study comparing 5 fractions in alternative days to standard 15 fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner patients aged above 50 years
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 |
|---|---|---|---|
| Hypofractionation | Radiation | — | UNRESOLVED |
| ultraHypofractionation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Hypofractionation
- description
- Control arm:patients who will receive standard 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
- interventionNames
- Radiation: Hypofractionation
- type
- EXPERIMENTAL
- label
- Ultrahypofractionation
- description
- Experimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
- interventionNames
- Radiation: ultraHypofractionation
Primary outcomes (4)
- measure
- Rate of Acute grade 2 or higher toxicity (NCI-CTCAE)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥50 years old. * Informed consent. * Either breast conservative surgery or mastectomy. * Invasive breast cancer with p T1-3, p N0-2. * Non metastatic breast cancer proven by clinical examinations and imaging (X-ray chest and ultrasound or CT scan chest and abdomen). Exclusion Criteria: * Evidence of distant metastases. * Prior irradiation. * Inflammatory breast cancer. * Tumor with T4 (skin nodules or fixed to chest wall or ulceration). * Tumor with positive margins.
References
Publications (0)
Data not yet available
No reference posted for this study.