3-Dimensional Conformal Radiation Therapy or Internal Radiation Therapy After Breast-Conserving Surgery in Treating Women With Stage I or Stage II Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether 3-dimensional conformal radiation therapy is more effective than internal radiation therapy when given after surgery in treating early-stage breast cancer. PURPOSE: This randomized phase II trial is studying 3-dimensional conformal radiation therapy to see how well it works compared with internal radiation therapy when given after breast-conserving surgery in treating women with stage I or stage II breast cancer.

Detailed Description
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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.

Official Title
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Phase II Randomised Clinical Trial of Accelerated Partial Breast Irradiation (APBI) Comparing 3-Dimensional Conformal Radiation Therapy and Multi-Catheter Interstitial Brachytherapy.

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: 3-dimensional conformal radiation therapy
* Radiation: brachytherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Radiation: 3-dimensional conformal radiation therapy<br>* Given twice a day for 10 fractions<br>|
| Experimental: Arm II<br>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. | Radiation: brachytherapy<br>* Given twice a day for 10 fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successfully delivered accelerated partial breast irradiation |  | Never established as trial terminated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control and pattern of recurrence |  | Never established as trial terminated | 
| Disease-free survival (distant and recurrence-free survival) |  | Never established as trial terminated | 
| Overall survival |  | Never established as trial terminated | 
| Quality of life (e.g., cosmesis and treatment-related symptoms) as assessed by the Breast Cancer Treatment Outcome and RTOG scales |  | Never established as trial terminated | 
| Acute radiation-induced toxicity as assessed by NCI CTCAE v3.0 |  | Never established as trial terminated | 
| Long-term radiation-induced toxicity as assessed by RTOG-EORTC scale |  | Never established as trial terminated | 
| Incidence and type of adverse events in the breast |  | Never established as trial terminated | 
| Incidence and type of procedure-related complications |  | Never established as trial terminated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IA breast cancer, stage IB breast cancer, stage II breast cancer, invasive ductal breast carcinoma