Status:
COMPLETED
Breast Cancer With Low Risk Of Local Recurrence: Partial and Accelerated Radiation With Three-Dimensional Conformal Radiotherapy (3DCRT) Vs. Standard Radiotherapy After Conserving Surgery (Phase III Study
Lead Sponsor:
Regione Emilia-Romagna
Conditions:
Breast Cancer
Eligibility:
FEMALE
49-85 years
Phase:
NA
Brief Summary
This study was designed and developed in the Emilia Romania research and innovation program (PRI ER). The study does not have commercial sponsors and comes under the independent studies provided for b...
Eligibility Criteria
Inclusion
- Histologically confirmed invasive breast cancer
- pT 1-2 (\< 3 cm in diameter) pN0-N1 M0 according to TNM classification.
- Unifocal disease (confirmed radiologically and histologically)
- Eligible histotypes: all except for non-epithelial histotypes (lymphoma, sarcoma)
- Hormonal receptor status: indifferent
- Patients undergoing conservative breast surgery for neoplasms with a diameter \< 3 cm and with biopsy of the sentinel lymph node or first instance axillary dissection.
- Breast resection margins histologically negative (³ 2 mm) at first intervention or after subsequent widening
- Radiological examination of the surgical specimen to assess the excision of the hidden lesions and/or the microcalcifications if present in the mammography carried out before surgery
- Positioning of 3-6 metallic clips, or in any case of an appropriate number to delineate the area of surgical exeresis (tumor bed)
- At least two weeks must have elapsed from the end of the chemotherapy if this is administered before the radiotherapy. In patients who do not receive chemotherapy, radiotherapy should start \< 12 weeks after surgery.
- No chemotherapy must be carried out during or at least two weeks after completion of the radiotherapy
- Treatment with tamoxifen or aromatase inhibitors is allowed at the same time
- Age ³ 49
- Gender: female
- Menopause status: unspecified
- Performance status: 0-2 according to ECOG
- Life expectation: at least five years
- INFORMED consent: yes
- Non-hormonal contraception in patients of childbearing age
Exclusion
- In situ carcinoma (CLIS and DCIS )
- Non-epithelial breast neoplasms (sarcoma, lymphoma etc.)
- Micro/macrometastases in \> 3 axillary lymph nodes; micro/macrometastases in the internal mammary and/or supraclavicular or subclavicular lymph nodes
- Multicentric carcinomas (lesions in different quadrants of the breast or in the same quadrant but separated by at least 4 cm) or clinically or radiologically suspected lesions in the ipsilateral breast, unless their tumoral nature was excluded through biopsy or fine needle sample.
- Palpable radiologically suspected ipsilateral or contralateral axillary, supraclavicular or infraclavicular, internal mammary nodes ( unless their tumoral nature was excluded through biopsy or fine needle sample)
- Treatments for previous contralateral or ipsilateral breast cancers
- Paget's disease of the nipple
- Cutaneous involvement, independently of the tumor diameter
- Distant metastases
- Previous radiotherapy on the thoracic region
- Previous neoadjuvant chemotherapy
- Collagen diseases (systemic erythematosus lupus, scleroderma, dermatomiositis)
- Other pathological conditions that limit life expectancy to \< 5 years
- Psychiatric diseases or disorders of other nature that prevent signing of informed consent for the treatment
- Other neoplasms in the last 5 years with the exception of skin tumors apart from melanoma and squamous intraepithelial lesions (SIL) of the uterine cervix
- Pregnancy and breast-feeding
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
3302 Patients enrolled
Trial Details
Trial ID
NCT01803958
Start Date
April 1 2007
End Date
January 1 2019
Last Update
March 27 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Unità Operativa di Radioterapia. Azienda USL di Bologna
Bologna, Italy, 40139