Clinical trial · Interventional
RCT Comparing 2 Radiotherapy HypoFractionation Schedules In Breast Cancer Patients
Randomized Clinical Trial Comparing Two Adjuvant Radiotherapy Hypo Fractionation Schedules In The Treatment of Post Mastectomy Breast Cancer Patients
NCT04550910CI-TRIAL-00047180BreastcancerunknownN/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)
This is a prospective randomized Phase III trial to assess efficiency of two post mastectomy hypofractionation schedules (40 Gy /15 fx / 3 weeks, 5 days per week VS 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy each week) as adjuvant radiotherapy in female patients with breast cancer after mastectomy.
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 |
|---|---|---|---|
| Locoregional Recurrence | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionation Schedules for Breast Cancer patients after mastecomy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm A
- description
- 40 Gy /15 fx / 3 weeks, 5 days per week, is a dose prescribed (after randomization ) for Breast Cancer patients indicated for adjuvant RTH after mastectomy
- interventionNames
- Radiation: Hypofractionation Schedules for Breast Cancer patients after mastecomy
- type
- EXPERIMENTAL
- label
- Arm B
- description
- 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy is a dose prescribed (after randomization )for Breast Cancer patients indicated for adjuvant RTH after mastectomy
- interventionNames
- Radiation: Hypofractionation Schedules for Breast Cancer patients after mastecomy
Primary outcomes (6)
- measure
- Chest wall pain
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Invasive carcinoma of the breast. * Complete microscopic excision of primary tumour and axillary dissection or SLNB . * Females with locally advanced breast cancer ( T3/T4 or N + or both ) who are candidate for neoadjvant chemotherapy regardless pathological stage after mastectomy. * Patients with pathological stage (T3/ T4, +/- N+) or ( N+, any T) after upfront mastectomy. * Able to comply with follow up. * Written informed consent Exclusion Criteria: * Patients do not match with inclusion criteria. * Collagen vascular disease, specifically systemic lupus, or scleroderma. * Pregnancy or lactation at the time of radiotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.