NL-OMON39567
Recruiting
Not Applicable
Breast cancer with low risk of recurrence:partial and accelerated radiation with three dimensional conformal radiotherapy (3DCRT) vs standard radiotherapy after conserving surgery (phase III study) - IRMA
Modena University Hospital0 sites420 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- breast cancer
- Sponsor
- Modena University Hospital
- Enrollment
- 420
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Females with Histologically confirmed invasive breast cancer pT 1\-2 (\< 3 cm in diameter) pN0\-N1 M0 .
- •\- Unifocal disease (confirmed radiologically and histologically)
- •\- 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 (\>\= 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 \> \=49
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Breast cancer subtype and distant recurrences after ipsilateral breast tumor recurrencesJPRN-UMIN000008136Collaborative Study Group of Scientific Research of the Japanese Breast Cancer Society300
Completed
Not Applicable
Randomised controlled trial in breast cancer genetic counselingGenetic counseling, web-based tailored info, communication, breast cancerCancerBreast cancer genetic counselingISRCTN82643064etherlands Institute for Health Services Research (NIVEL) (The Netherlands)200
Completed
Not Applicable
Selection of Breast Cancer Patients with Low-risk Tumors using MR ImagingNL-OMON36966niversitair Medisch Centrum Utrecht60
Not yet recruiting
Not Applicable
Effect of anaesthetic technique on the recurrence of breast cancer after surgery.CTRI/2021/12/038966nil
Recruiting
Phase 2
In women with breast cancer, does Accelerated Partial Breast Irradiation (APBI) demonstrate acceptable general cosmesis with an improved quality of life?ACTRN12613000551796Dr Yaw Chin.60