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A Randomized Phase III Study of Conventional Whole Breast Irradiation
(WBI) vs. Partial Breast Irradiation (PBI) for Women with Stage
0, I or II Breast Cancer (some limitations as of 12/12/06)
Women with Stage 0 (DCIS), I or II breast cancer; If Stage II,
tumor size must be < 3.0 cm; Surgical treatment of the breast
must have been lumpectomy; women with invasive breast cancer are
required to have axillary staging that can include sentinel biopsy
alone (if sentinel node is negative), sentinel node biopsy followed
by axillary dissection or sampling with a minimum total of 6 axillary
nodes (if sentinel node is positive), or axillary dissection alone
(with a minimum of 6 axillary nodes); Axillary staging is not required
for patients with DCIS; For a woman to be eligible, she can have
no more than 3 axillary nodes that are histologically positive;
Margins of resected specimen must be histologically free of cancer
including DCIS; Target lumpectomy cavity must be clearly delineated
and the target lumpectomy cavity/whole breast reference volume
must be < 30% based on the postoperative/pre-randomization CT
scan; Women must be registered to the study within 42 days following
the last surgery for breast cancer (e.g., lumpectomy, re-excision
of margins or axillary staging procedure).
Group 1 – Whole Breast Irradiation:
45-50 Gy in 25 (1.8 – 2.0 Gy) fractions to whole breast,
followed by optional boost to > 60 Gy.
34 Gy in 3.4 Gy fractions using multi-catheter brachytherapy.
or
Group 2 – Partial Breast Irradiation:
34 Gy in 3.4 Gy fractions using MammoSite® balloon catheter.
or
38.5 Gy in 3.85 Gy fractions using 3-D conformal external beam
radiation. For all PBI techniques: RT given to index quadrant only,
BID (with a fraction separation of at least 6 hours), for a total
of 10 treatments given on 5 days over a period of 5 to 10 days.
3,000
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