Advanced Radiotherapy in Carcinoma Breast.

Not yet recruiting

Brief Summary: This study is an observational study.Patients with breast cancer in whom 3D-CRT isdeemed inadequate and are considered to be treated with VMAT technique, will beenrolled if they meet the eligibility criteria. The treatment will be as perthe standard practice of the department. Demographic data and clinical detailswill be collected from the out-patient records of the patients. In addition toVMAT, a 3D-CRT plan will be generated for the same volumes for the purpose ofcomparing the two techniques from dosimetric point-of-view. Various planrelated parameters will be recorded on the proforma.Patients will be evaluated during the courseof their treatment as per the routine practice, on a weekly basis, and theiracute toxicities will be recorded.

Following completion of radiotherapy, thepatients will be advised follow-up at 1 month and 3 monthly thereafter for 1.5years. During follow-up, patients will be enquired regarding the presence andseverity of any local symptoms following treatment. They will be examined forany evidence of recurrent disease and evaluated for toxicities. They will beasked to grade the cosmetic outcome according to Harvard/RTOG Cosmesis gradingscale before treatment, just after completing treatment, at 1 month, 4 months,7 months, and 10 months follow up. Quality of Life analysis will be done before starting treatment and 4 months after completion of treatment during regular follow up.

Recruitment & Eligibility

Inclusion Criteria

Patients with breast cancer requiring adjuvant radiotherapy following either BCS or MRM, but cannot be adequately treated with 3D-CRT, and thereby require IMRT based RT planning.
Criteria: a.Tumor coverage V95 < 90%.
b.Homogeneity Index > 0.1. c.V105 > 5% of the tumor.
d.V10 <15-20% of heart.
e.Ipsilateral lung dose <25%.
f.Internal mammary lymph node positive cases.
g.B/L breast cancer.
Willing to participate in the study and provides a voluntary informed consent.

Exclusion Criteria

Metastatic disease, and patients being considered for loco-regional radiotherapy with an intent to palliation.
History of prior radiation, connective tissue disorders or other comorbidities that could put the patient at higher risk of developing treatment related toxicities.

Primary Outcome Measures

Name	Time	Method
Dosimetric comparison of tumor coverage and normal tissue exposure between VMAT technique with conventional 3DCRT Technique in adjuvant radiotherapy for breast cancer.	September 2021

Secondary Outcome Measures

Name	Time	Method
1.To report the acute toxicities of treatment.	2.To evaluate local control rates following VMAT based EBRT.

Locations (1): Kasturba Medical College
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical College
🇮🇳Udupi, KARNATAKA, India
Dr Nikunj Patil
Principal investigator
9404712015
drnikunj.work@gmail.com