Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences as well as improving survival in node positive breast cancer patients. PMRT for women with T1-T2 tumors and negative axillary nodes is not generally warranted because of the presumed low risk of recurrence in this population as a whole. However, in the setting of multiple adverse prognostic factors, the recurrence risk approaches and in some cases surpasses the risk of recurrence documented for patients with one to three positive lymph nodes. Numerous retrospective series have reported the outcome and patterns of failure for post-mastectomy patients treated without radiation. Many of these series have analyzed several high risk factors which were predictive of loco-regional recurrence wherein the role of adjuvant post-mastectomy radiation can be considered. Some authors have used combinations of prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and lympho-vascular space invasion to define subgroups with more specific risks of loco-regional recurrence than single factors alone. The current trial hypothesizes that "Post-mastectomy radiation in high risk, node negative early breast cancer patients decreases rates of loco-regional recurrence and improves disease free survival" and propose to address the question in randomized setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,022
Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks
Post Graduate Institute of Medical Education & Research
Chandigarh, Chandigarh, India
RECRUITINGKolhapur Cancer Centre Pvt Ltd
Kolhāpur, Maharashtra, India
NOT_YET_RECRUITINGTata Memorial Centre
Mumbai, Maharashtra, India
RECRUITINGMax Super Speciality Hospital, Shalimar Bagh
Delhi, National Capital Territory of Delhi, India
NOT_YET_RECRUITINGMax Super Speciality Hospital(A unit of Devki Devi Foundation)
New Delhi, National Capital Territory of Delhi, India
NOT_YET_RECRUITINGAll India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
NOT_YET_RECRUITINGBhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur, Rajasthan, India
NOT_YET_RECRUITINGDisease free survival
This will be measured using Kaplan Meier time to event analysis
Time frame: 5 years
Chest wall recurrence
This is the incidence of local recurrence in the chest wall
Time frame: 5 years
Regional recurrence
This is the incidence of recurrence in the regional lymphatics
Time frame: 5 years
Metastasis-free survival
This will be measured using Kaplan Meier time to event analysis
Time frame: 5 years
Overall survival
This will be measured using Kaplan Meier time to event analysis
Time frame: 5 years
Acute Morbidity of radiotherapy
RTOG Acute radiation morbidity scoring
Time frame: 4 weeks from the start of radiotherapy
Late Morbidity of radiotherapy
RTOG Late radiation morbidity scoring
Time frame: 6 months from end of radiotherapy to 5 years
Quality of life scores under different domains of the QLQ C-30 and BR-23 questionnaires
Quality of life will be assesses by EORTC QLQ C-30 core questionnaire and the breast cancer specific module BR-23 questionnaire
Time frame: 5 years post surgery
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