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

NCT ID: NCT00802711

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-08-31

Brief Summary

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

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Given twice a day for 10 fractions

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.

Group Type: EXPERIMENTAL

brachytherapy

Intervention Type: RADIATION

Given twice a day for 10 fractions

Interventions

3-dimensional conformal radiation therapy

Given twice a day for 10 fractions

Intervention Type: RADIATION

brachytherapy

Given twice a day for 10 fractions

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Trials Ireland

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Thirion, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Luke's Hospital

Locations

Saint Luke's Radiation Oncology Network

Dublin, , Ireland

Countries

Ireland

Other Identifiers

ICORG-06-33

Identifier Type: -

Identifier Source: secondary_id

EU-20888

Identifier Type: -

Identifier Source: secondary_id

06-33 ICORG

Identifier Type: -

Identifier Source: org_study_id