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

Cancer Trials Ireland

Status: Terminated

Conditions: Breast Cancer

Treatments: Radiation: brachytherapy; Radiation: 3-dimensional conformal radiation therapy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00802711

ICORG-06-33

EU-20888

06-33 ICORG

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 patients

Sex: Female

Ages: 50 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Arm I

Experimental group

Description:

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.

Treatment:

Radiation: 3-dimensional conformal radiation therapy

Arm II

Experimental group

Description:

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.

Treatment:

Radiation: brachytherapy