Phase II Randomised Clinical Trial of Accelerated Partial Breast Irradiation (APBI) Comparing 3-Dimensional Conformal Radiation Therapy and Multi-Catheter Interstitial Brachytherapy.
50 Years
N/A
Female
Breast Cancer
Trial Information
Phase II Randomised Clinical Trial of Accelerated Partial Breast Irradiation (APBI) Comparing 3-Dimensional Conformal Radiation Therapy and Multi-Catheter Interstitial Brachytherapy.
OBJECTIVES:
Primary
- To compare the rate of successfully delivered accelerated partial breast irradiation
(APBI) using 3-dimensional conformal radiation therapy vs multi-catheter interstitial
brachytherapy in women with stage I or II invasive ductal carcinoma of the breast.
- To establish potential patient participation in ongoing phase III clinical trials
(e.g., NSABP-B-39, GEC-ESTRO, RAPID, MPORT, and IRMA) that compare APBI to standard
whole-breast irradiation.
Secondary
- To assess acute radiation-induced toxicity in these patients as assessed by NCI CTCAE
version 3.0.
- To assess long-term radiation-induced toxicity in these patients as assessed by
RTOG-EORTC scale.
- To assess the incidence and type of adverse events in the breast of these patients.
- To assess the incidence and type of procedure-related complications in these patients.
- To determine local control and pattern of recurrence in these patients.
- To determine disease-free survival (distant and recurrence-free survival) of these
patients.
- To determine overall survival of these patients.
- To assess cosmesis in these patients as assessed by the Breast Cancer Treatment Outcome
and RTOG scales.
- To assess treatment-related symptoms in these patients as assessed by the Breast Cancer
Treatment Outcome scale.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with a lumpectomy
cavity/whole breast ratio 25-30% are assigned to treatment in arm II.
- Arm I: Patients undergo accelerated partial breast irradiation (APBI) using
3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10
fractions) in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo APBI using multi-catheter interstitial brachytherapy twice
daily over 5-10 days (total of 10 fractions) in the absence of disease progression or
unacceptable toxicity.
Patients complete quality-of-life questionnaires at baseline, on the last day of treatment,
at 4 and 24 weeks after completion of treatment, and then annually for 3 years.
After completion of study treatment, patients are followed periodically for at least 5
years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Pathologically proven invasive ductal carcinoma of the breast
- Stage I or II disease (pathological tumor size ≤ 3 cm, N0, M0 disease)
- No T2 (tumor size > 3 cm) or T3 disease
- No lymph node (L0) or hemangiosis (V0) invasion
- Unilateral, unifocal, and unicentric tumor without associated suspicious diffuse
microcalcification in the ipsilateral or contralateral breast
- No multifocal/multicentric disease
- Previously treated with breast-conserving surgery with adequate axillary node
management
- Negative surgical resection margins for tumor (invasive tumor or ductal
carcinoma in situ [DCIS]) on histology
- Clearly identified primary tumor excision cavity (clips recommended) with a
target lumpectomy cavity/whole breast ratio quantifiable and ≤ 25% on the
post-operative CT scan
- Patients with a lumpectomy cavity/whole breast ratio 25-30% are eligible
but will undergo partial breast irradiation using multi-catheter
interstitial brachytherapy during study
- Breast size amenable to partial breast irradiation (i.e., > A-cup size)
- No other pathological invasive tumor or DCIS
- No associated extensive DCIS component (< 25%)
- No associated Paget's disease of the nipple
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No breast implants
- No collagen vascular disease
- No psychiatric condition or other condition that, in the opinion of the investigator,
would preclude study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy
- No concurrent chemotherapy
- Sequential chemotherapy allowed
- Concurrent hormonal therapy allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of successfully delivered accelerated partial breast irradiation
Outcome Time Frame:
Never established as trial terminated
Safety Issue:
No
Principal Investigator
Pierre Thirion, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Saint Luke's Hospital
Authority:
Ireland: Health Information and Quality Authority
Study ID:
CDR0000628759
NCT ID:
NCT00802711
Start Date:
September 2008
Completion Date:
August 2011
Related Keywords:
- Breast Cancer
- stage IA breast cancer
- stage IB breast cancer
- stage II breast cancer
- invasive ductal breast carcinoma
- Breast Neoplasms
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