Clinical trial · Interventional
Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer
Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer: A Single Institution Feasibility Study
NCT04580784CI-TRIAL-00047579unknownPhase 2ClinicalTrials.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)
The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.
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 Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Weekly hypofractionation for early breast cancer | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionation
- description
- Hypofractionated whole breast radiotherapy using a dose of 28.5 Gy over 5 fractions with once weekly fractions.
- interventionNames
- Radiation: Weekly hypofractionation for early breast cancer
Primary outcomes (4)
- measure
- Change in cosmetic breast appearance
- timeFrame
- six months
- description
- according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor
- measure
- Acute radiation toxicity assessment
- timeFrame
- six months
- description
- according to the RTOG acute toxicity scale: 0 No visible change, 1 faint/dull erythema, 2tender/ bright +- dry desquamation, 3 patchy moist desquamation, 4 conflueunt moist desquamation, pitting edema, 0 is the best and 4 is the worse.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven diagnosis of invasive breast adenocarcinoma. 2. Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery). 3. No macroscopic evidence of distant metastases at diagnosis. Exclusion Criteria: 1. Prior radiation to the thoracic region. 2. Pregnancy. 3. Patients with synchronous or prior malignancy. 4. Positive surgical margins.
References
Publications (0)
Data not yet available
No reference posted for this study.