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

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: 3-dimensional conformal radiation therapy; Radiation: brachytherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 6
    • Saint Luke's Radiation Oncology Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Radiation: 3-dimensional conformal radiation therapy; Given twice a day for 10 fractions
Experimental: 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.	Radiation: brachytherapy; Given twice a day for 10 fractions

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland
• Investigators: Principal Investigator: Pierre Thirion, MD, Saint Luke's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: December 4, 2008
• First Submitted That Met QC Criteria: December 4, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: stage II breast cancer; stage IA breast cancer; stage IB breast cancer; invasive ductal breast carcinoma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 06-33 ICORG; ICORG-06-33; EU-20888