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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2016/12/007532 | Registry Identifier | Clinical Trial Registry- India |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post Mastectomy Radiation Therapy (PMRT) | Experimental | Post mastectomy radiotherapy will be given |
|
| Observation (No PMRT) | No Intervention | No adjuvant radiotherapy will be given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post Mastectomy Radiation therapy | Radiation | Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | This will be measured using Kaplan Meier time to event analysis | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Chest wall recurrence | This is the incidence of local recurrence in the chest wall | 5 years |
| Regional recurrence | This is the incidence of recurrence in the regional lymphatics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tabassum Wadasadawala, MBBS,MD,DNB | Contact | 02227405078 | twadasadawala@actrec.gov.in |
| Name | Affiliation | Role |
|---|---|---|
| Tabassum Wadasadawala, MBBS,MD,DNB | Assistant Professor, Radiation Oncology, Tata Memorial Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Post Graduate Institute of Medical Education & Research | Recruiting | Chandigarh | Chandigarh | 160012 | India |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Arm Experimental Post Mastectomy Radiotherapy Arm No Intervention: No Post Mastectomy Radiotherapy
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|
| 5 years |
| Metastasis-free survival | This will be measured using Kaplan Meier time to event analysis | 5 years |
| Overall survival | This will be measured using Kaplan Meier time to event analysis | 5 years |
| Acute Morbidity of radiotherapy | RTOG Acute radiation morbidity scoring | 4 weeks from the start of radiotherapy |
| Late Morbidity of radiotherapy | RTOG Late radiation morbidity scoring | 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 | 5 years post surgery |
| Kolhapur Cancer Centre Pvt Ltd | Not yet recruiting | Kolhāpur | Maharashtra | 416234 | India |
|
| Tata Memorial Centre | Recruiting | Mumbai | Maharashtra | 400012 | India |
|
| Max Super Speciality Hospital, Shalimar Bagh | Not yet recruiting | Delhi | National Capital Territory of Delhi | 110088 | India |
|
| Max Super Speciality Hospital(A unit of Devki Devi Foundation) | Not yet recruiting | New Delhi | National Capital Territory of Delhi | 110017 | India |
|
| All India Institute of Medical Sciences | Not yet recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
|
| Bhagwan Mahaveer Cancer Hospital and Research Centre | Not yet recruiting | Jaipur | Rajasthan | 302017 | India |
|
| D017437 |
| Skin and Connective Tissue Diseases |