C50 Cancer de mama
Conditions
Interventions
None listed
Sponsors
Agencia Internacional de Energia Atomica (IAEA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients must be over 18 years of age and under 81 years of age. • WHO (ECOG) Status 0-2 (see appendix 2) • Histologically confirmed diagnosis of infiltrating carcinoma of the breast, lobular or mixed carcinoma (ductal and lobular) • Patients must have had modified radical mastectomy (MRM) in which 6 or more nodes were removed. • All patients should receive adjuvant chemotherapy after surgery (MRM) The initiation of radiation therapy should be initiated once hematologic recovery has been achieved. • 6 Patients must have received adjuvant chemotherapy according to one of the two regimens found in Appendix 3. • Margins of negative surgery due to histopathology at the time of the MRM • Patients with TNM stages starting MO: pTl NI, PT2 NI, pT3 NO, pT = N2, pTl N2, pT2 N2, T3 NI, pT3 N2 • Histological grades 1-3 (WHO criteria) • Patients must return for scheduled treatment and follow-up • Sign informed consent.
Exclusion criteria
Exclusion criteria: • Pathology pN3 (metastasis with 10 or more lymph nodes, clinically internal mammary metastasis, metastasis to the supraclavicular lymph node chain. • Stages IIIB, IIIC and IV (some T4, N3 or MI) • Recurrence of breast cancer followed by MRM and / or adjuvant chemotherapy. • primary contralateral concomitant breast cancer • History of another malignancy except carcinoma in situ of the cervix or non-melanoma skin cancer • Pregnancy or lactation • Previous chemotherapy or another such as adjuvant chemotherapy for the treatment of breast cancer present. • Another severe concomitant disease that could impact the ability to give treatment or increase the risk of toxicity. • Contraindications of radiotherapy • Severe psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control in the chest wall will be measured at the time of each post-radiation therapy visit. The presence of recurrent disease in the surgical scar, ipsilateral chest wall, ipsilateral skin and soft tissue will indicate failure of local control. NAME OF THE RESULT: Local Control PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control in the chest wall will be measured at the time of each post-radiation therapy visit. The presence of recurrent disease in the surgical scar, ipsilateral chest wall, ipsilateral skin and soft tissue will indicate failure of local control. NAME OF THE RESULT: Local Control PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After treatment;The presence of recurrent disease in the axilla, ipsilateral supraclavicular/infraclavicular nodes and or ipsilateral skin/soft tissue in the regional areas will indicate failure of regional control. Failure within the bounds of the supraclavicular field will be assessed separately. NAME OF THE RESULT: Regional Control PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After treatment;Disease-free status will be measured at the time of each post-radiation therapy visits Failure is defined as the presence of recurrent disease at local, regional and distant sites, inciudinq recurrence in the contralateral breast. NAME OF THE RESULT: Disease-free Survival PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: After treatment;Deaths due to any cause at any time during treatment or after the completion of treatment will be recorded and used in the calculation of overall survival (described below). If a significant number of accidental deaths or deaths from diseases unrelated to treatment (e g from infectious diseases occurring more than 3 months after the completion of therapy from prexisting co-morbidities or from diseases that do not appear to be a consequence of late effects) are observed (as is quite likely in developing countries), overall survival will also be calculated when patients who die from unrelated causes, as defined, are excluded. NAME OF THE RESULT: Overall survival PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE | — |
Countries
Peru
Outcome results
None listed