Clinical trial · Observational
Impact of Tumor Bed Localisation on Dosimetry Boost Irradiation in Patients Undergoing Breast Conserving Surgery
Localisation of Tumor Bed and Its Impact on Dosimetry for Tumor Bed Boost Irradiation in Patients Treated With Breast Conserving Surgery Using Different Techniques
- 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)
PRIMARY STUDY OBJECTIVES: To evaluate dosimetric outcomes in tumor bed boost irradiation in patients undergoing breast conservative surgery using three different surgical techniques SECONDARY OBJECTIVES- Evaluation of cosmesis in patients prior to radiotherapy, at the time of completion of radiotherapy and 6 months post completion of radiotherapy STUDY DESIGN: Three arm, Prospective Observational Trial TREATMENT REGIMEN: Group A- Patients who underwent open cavity Breast Conservative surgery(BCS) Group B- Patients who underwent closed cavity BCS Group C- Patients who underwent oncoplasty All patients will first receive external beam Radiotherapy to the whole breast to a dose of 40 Grays /15#/3 weeks. The patients will then be planned for boost radiation to the tumor bed to a dose of 12.5 Grays/5#. RECRUITMENT TARGET: 20 Patients The sample size has not been calculated as this is a pilot study. Twenty patients will be accrued for the purpose of this study PRIMARY ENDPOINT 1. Dosimetric Measurement * Seroma cavity volume (ccs). * PTV volume (ccs). * Ratio between the PTV volumes to the whole breast volume * Radiation Conformity Index (RCI) * Dose Homogeneity Index (DHI) * Ratio of dose received by 95% of PTV volume to the dose received by 5% of PTV volume * Dose received by several normal structures; normal ipsilateral breast tissue, contralateral breast, ipsilateral lung, contralateral lung, and heart 2. Cosmesis Measurement * prior to starting radiotherapy, * at the time of conclusion of radiotherapy * 6 months post completion of radiotherapy
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- A Patient who underwent open cavity BCS
- description
- Patients undergoing Open cavity Breast Conservative Surgery
- label
- B Patient who underwent close cavity BCS
- description
- Patients undergoing Close cavity Breast Conservative Surgery
- label
- C Patient who underwent oncoplasty
- description
- Patients undergoing oncoplasty for breast cancer
Primary outcomes (2)
- measure
- Volume of PTV
- timeFrame
- at the time of radiation planning
- description
- measured in cubic centimeter
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1.All patients undergoing Breast Conservative Surgery (Open Cavity/Closed Cavity) or Oncoplasty will be eligible for this study. Exclusion Criteria: 1. Patients undergoing Neoadjuvant chemotherapy will not be eligible for the purpose of this study. 2. All patients undergoing Modified Radical Mastectomy will not be eligible for the purpose of this study
References
Publications (0)
Data not yet available