Clinical trial · Interventional
Hypofractionated Radiation Therapy vs Standard Treatment in Breast Cancer.
Hypofractionated Radiation Therapy (1 Week) Compared With Standard Treatment (3.1 Weeks), Evaluation of Local Control of Breast Cancer Treated With Conservative Surgery.
- 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)
An explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy DCIS, T1-T2 N0 M0 (AJCC v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. Shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
| Stage 0 Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM I
- description
- Radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast.
- interventionNames
- Radiation: Hypofractionated radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- ARM II
- description
- Radiotherapy treatment with standard hypofractionation, 42.5 Gy in 16 fractions with simultaneous integrated increase of 5.5 Gy to the tumor bed in high-risk patients.
- interventionNames
- Radiation: Hypofractionated radiotherapy
Primary outcomes (2)
- measure
- Identify the progression timing.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed by histopathological report of ductal carcinoma in situ (DCIS) or invasive breast carcinoma. * Treated with breast-conserving surgery and stage pT1-2 pN0 M0. * Over 18 years. * Patients who sign informed consent for research study. Exclusion Criteria: * Positive nodes. * Clinical or pathological stage T3-T4. * History of previous irradiation. * Postoperative positive margin.
References
Publications (0)
Data not yet available