The study proposes to evaluate whether partial hypofractionated and accelerated irradiation of the sole surgical cavity, in patients suffering from breast cancer with low risk of local recurrence and who undergo conservative surgery, is not inferior…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
survival free of local ipsilateral recurrence as prime event
Secondary outcome
global survival, locoregional recurrence-free, distant recurrence-free, acute
and late toxicity (RTOG) and cosmetic result
Background summary
Irradiation of the breast after surgery of a tumor in the breast reduces the
risk of recurrence in the breast (local recurrence). The standard irradiation
consists of 25 to 33 fractions in 5 to 6.5 weeks. The whole breast is
irradiated and in most cases a boost is given on the original tumor bed.
Recently several research groups have suggested that irradiation of only the
part of the breast, where the tumor was situated, could be sufficient for
patients, who have a low risk for local recurrence.
The irradiated volume is much smaller, when partial breast irradiation is used
instead of irradiation of the whole breast. The irradiation dose that is
needed for partial irradiation can be administered in a shorter time: in this
study 10 fractions will be administered, twice a day during five consecutive
working days.
Study objective
The study proposes to evaluate whether partial hypofractionated and accelerated
irradiation of the sole surgical cavity, in patients suffering from breast
cancer with low risk of local recurrence and who undergo conservative surgery,
is not inferior to postoperative irradiation with conventional fractionation of
the entire breast as regards local control (incidence of ipsilateral
recurrences as prime event)
Study design
Multicenter phase III controlled randomized, unblinded study of
non-inferiority.
Intervention
RADIOTHERAPY:
•Trial arm 38.5 Gy total in 10 fractions (3.85 Gy per fraction), twice a day
with an interval of at least 6 hours between the two fractions, for five
consecutive working days.
• Control arm 45 Gy/18 fractions, or 50 Gy/25 fractions, or 50,4 Gy/28
fractions , 1 fraction/day, 5 fractions/week +/- 10 - 16 Gy boost in 5-8
fractions, according to the institutional policy of each participating center.
Study burden and risks
Irradiation of the breast may lead to slight swelling of the breast and a skin
reaction, both are reversibel.
Another risk may be that partial breast irradiaton increases the risk of
recurrence of the disease outside the irradiated area compared to standard
irradiation of the whole breast. That is why this study is only for patients
with a low risk for recurrence of disease
Via del Pozzo 71
Modena 41100
IT
Via del Pozzo 71
Modena 41100
IT
Listed location countries
Age
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
- performance status 0-2
- life expectancy at least 5 years
- written informed consent
- Non-hormonal contraception in patients of childbearing age
- Patients technically eligible for radiotherapy
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
•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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27657.028.09 |