Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast
Conditions
Interventions
Intervention1: Radiation therapy to involved breast and regional nodes: After systemic therapy, Radiation to involved breast and nodal areas upto a total dose of 5000 cGy in 25 fractions followed by t
Sponsors
Cancer Institute WIA
Eligibility
Inclusion criteria
Inclusion criteria: 1.All female patients with histologically proven or radiologically confirmed MBC 2.Age between 18-70 years 3.Estimated life expectancy of at least 1 year during the time of recruitment in the study 4.Karnofsky performance status score =60. 5.Normal cardiac function with echocardiography showing Ejection Fraction (EF) 50% or more. 6.The subset of oligometastatic patients who, after the completion of systemic therapy, continue to remain inoperable or have oligometastatic disease not amenable for local treatments and are not offered MRM will be considered for the trial
Exclusion criteria
Exclusion criteria: 1.Any previous history of cancer treatment 2.Patients with oligo-metastasis amenable for curative intent of treatment and treated with MRM followed by sequential RT 3.Patients with symptomatic brain metastasis with features of raised intracranial pressure at the time of study recruitment 4.Patients with multiple liver metastasis and grossly deranged LFT (SGOT (AST) > 4.0 x upper limit of normal (ULN) and SGPT (ALT) >4.0 x ULN and Bilirubin >1.5 x ULN) at the time of study recruitment 5.Patients with significant residual disease post systemic therapy at the time of randomization who will require palliative RT for local control 6.Patients with extensive cutaneous nodules and disease extending beyond the confines of the breast and impossible to encompass within the radiation fields during study recruitment 7.History of previous radiation therapy to the affected breast 8.Patients not consenting to treatment 9.The patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS)Timepoint: To compare the OS of loco-regional RT verses no RT in MBC after systemic therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) and Quality of Life (QOL)Timepoint: •To compare the PFS between the RT verses no RT arm •To evaluate the effect of RT on local control of primary tumor in MBC and compare it with the no RT arm. •To assess the toxicity because of RT in the intervention arm •To compare the quality of life between both treatment arm. | — |
Countries
India
Contacts
Public ContactPriya Iyer
Cancer Institute (W.I.A)
Outcome results
None listed