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Impact of Tumor Bed Localisation on Dosimetry Boost Irradiation in Patients Undergoing Breast Conserving Surgery

NCT03710018 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2018-10-17

No results posted yet for this study

Summary

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

  • Breast Carcinoma

Sponsors & Collaborators

  • Tata Memorial Centre

    lead OTHER

Principal Investigators

  • Ashwini Budrukkar, MD, DNB · Associate Professor, Tata Memorial Center, Mumbai India

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03710018 on ClinicalTrials.gov