Health Condition 1: C500- Malignant neoplasm of nipple and areola Health Condition 2: C501- Malignant neoplasm of central portion of breast Health Condition 3: C502- Malignant neoplasm of upper-innerquadrant of breast Health Condition 4: C503- Malignant neoplasm of lower-innerquadrant of breast Health Condition 5: C504- Malignant neoplasm of upper-outerquadrant of breast Health Condition 6: C505- Malignant neoplasm of lower-outerquadrant of breast Health Condition 7: C506- Malignant neoplasm of
Conditions
Interventions
Intervention1: Radiotherapy: Patient will be treated with standard accelerated hypo fractionated post surgery of dose dose equivalent to 34 Gy in 10 fractrions
Control Intervention1: Radiotherapy: Pat
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female 2.more than or equal to 18 years of age 3.Invasive carcinoma of breast (cT1-3,N0-2a) 4.Post breast conserving surgery/mastectomy, with clear margin of more than or equal to 1mm, with or without axillary lymph node dissection for breast cancer(pT0-T3,N0-2a) 5.Written informed consent 6.Able to comply with follow-up up to 6 months
Exclusion criteria
Exclusion criteria: 1.Advanced loco-regional disesase- cT4/ cN2b/cN3 tumors, known residual macroscopic local or nodal disease post-surgery, requirement for Internal mammary nodal RT (more than or equal to 4axillary nodal macrometastasis, radiologically positive IMN), Positive margin, 2.Metastatic disease 3.Breast reconstruction 4.Pregnancy 5.Prior radiotherapy in the thoracic and /or lower neck area 6.Past history of malignancy except (i) basal cell skin cancer, (ii) CIN cervix uteri or (iii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free 7.Contralateral and/or previous ipsilateral breast cancer, including DCIS, irrespective of date of diagnosis 8. Patients at low risk, eligible and willing for Accelerated partial breast irradiation (more than or equal to 50 years of age, tumor less than oe equal to 2 cm, ER-Positive, Her-2-neu -Negative, Grade 1-2, unicentric, unifocal, no EIC, LVSI, Node negative, clear surgical margin at least 2mm, no genetic mutation, no lobular pathology)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To compare the proportion of patients with cumulative more than or equal to grade 2 dermatitis according to RTOG Acute & CTCAE Version 5, anytime during or within 3 months post radiotherapyTimepoint: during radiotherapy or within 3 months post radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the time to first occurrence of more than or equal to grade 2 skin toxicitiesTimepoint: first occurrence of more than or equal to grade 2 skin toxicities;To compare the change in EORTC Quality of life C30 score and EORTC BR 45 score from baseline prior to radiotherapy, to 6 months post radiotherapyTimepoint: 6 months post radiotherapy;To compare the proportion of patients with acute toxicities other than skin, according to RTOG Acute & CTCAE Version 5 Grades during and within 3 months post radiotherapy.Timepoint: 3 months post radiotherapy;To compare the proportion of dosimetric feasibility on treatment planning as per protocol, between two radiation dose prescriptionsTimepoint: start of radiotherapy;To compare the proportion of patients with ipsilateral local and or regional nodal relapse at 6 months post radiotherapyTimepoint: 6 months post radiotherapy;To compare the proportion of patients with late toxicities at 3-6 months according to RTOG Late & CTCAE Version 5 Grades post radiotherapyTimepoint: 6 months post radiotherapy | — |
Countries
India
Contacts
Public ContactDr Pooja Sethi
JIPMER
Outcome results
None listed