Clinical trial · Interventional
Simultaneous Integrated Boost With Volumetric Arc Radiotherapy in Patients With Breast Cancer
A Phase II Study of Simultaneous Integrated Boost With Volumetric Arc Radiotherapy After Breast Conservative Surgery in Patients With Breast Cancer
- 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 study will include 27 patients to study the dosimetric data and acute toxicity. Patients will be treated by SIB intensity modulated radiotherapy (IMRT) boost to the cavity.The dose to be delivered will be a hypo fractionated regimen of 34Gy/10#/2weeks to the whole breast and 40Gy/10#/2weeks to the tumour bed. The dose to the target and to the OAR will be observed. The acute toxicity and cosmesis will be assessed.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Acute radiation toxicities
- timeFrame
- one month after completion of treatment
- description
- Acute skin toxicities will be assessed using RTOG acute toxicity scoring scale after one month of completion of treatment.
Secondary outcomes (3)
- measure
- cosmetic score analysis
- timeFrame
- 6 months, 1 year and 3 years off follow up.
- description
- NSABP/HARVARD/RTOG criteria Pigmentary change : 0 = None 1 = Transitory , slight 2 = Permanent , marked Breast edema : 0 = None 1 = Asymptomatic 2 = Symptomatic 3 = Secondary dysfunction
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Primary cancer of breast of any histology, * age 18-60 years, * post BCS, * KPS \>70, * no distant metastasis and patients who have or have not received chemotherapy Exclusion Criteria: * History of prior primary malignancy, * prior irradiation to breast or chest, * pregnant or lactating women, and * collagen vascular disease
References
Publications (0)
Data not yet available