Clinical trial · Interventional
Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation
Standard Versus Investigatioinal Fractionation Trial - Nodal Radiation
NCT04909125CI-TRIAL-00102681active not recruitingN/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)
The purpose of this study is to investigate the difference in fatigue, quality of life and radiation morbidity between hypofractionated and conventional radiation to the breast, chest wall and regional lymph nodes post mastectomy or lumpectomy
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 |
| Post Mastectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Hypofractionation Arm
- description
- 40Gy / 15 fractions, 2.67Gy per fraction, over 3.5 week (9 fractions per fortnight)
- interventionNames
- Radiation: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy
- type
- OTHER
- label
- Standard /Conventional fractionation Arm
- description
- 50Gy / 25 fractions, 2Gy per fraction, over 5.5 week (9 fractions per fortnight)
- interventionNames
- Radiation: Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy
Primary outcomes (1)
- measure
- Fatigue
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years and older * ECOG performance status 0-2 * Ability to understand and willingness to sign a written informed consent document * Stage pT1-3, pN0-3, M0 histologically proven breast cancer no matter the status of ER/PR/HER2 receptor testing * Managed with either mastectomy or breast conserving surgery * Suitable for radiation therapy to the breast/chest wall and regional lymph nodes * Neoadjuvant and adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 therapy is accepted * Neoadjuvant radiotherapy (reverse sequencing) accepted * Breast implants and expanders are accepted * Patients with connective tissue disease are allowed if the treating radiation oncologist finds radiation therapy indicated * Life expectancy minimum 10 years * Patients with non-breast malignancies are accepted if the patient has been disease free for five years and/or has a low risk of recurrence as estimated by the treating radiation oncologist (to be determined at initial patient appointment) Exclusion Criteria: * Prior radiotherapy to the ipsilateral breast or chest wall * Pregnancy or lactation * Radiosensitivity syndrome * Permanent pacemaker/defibrillator within radiotherapy field * Oncoplastic surgery where boost volume unacceptable (clinician discretion) * Conditions indicating that the patient cannot go through radiation therapy or follow up, or a condition where the treating oncologist thinks the patient should not participate in the trial (for example, language barriers)
References
Publications (0)
Data not yet available
No reference posted for this study.