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

NCT00802711 | Terminated

• 3 other identifiers: 06-33 ICORGICORG-06-33EU-20888
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage IA breast cancer; stage IB breast cancer; stage II breast cancer; invasive ductal breast carcinoma

Outcome Measures

Primary Outcomes (1)

• Rate of successfully delivered accelerated partial breast irradiation

  Never established as trial terminated

Secondary Outcomes (8)

• 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

Study Arms (2)

Arm I

EXPERIMENTAL

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

Arm II

EXPERIMENTAL

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

Interventions

brachytherapy RADIATION

Given twice a day for 10 fractions

Arm II

3-dimensional conformal radiation therapy RADIATION

Given twice a day for 10 fractions

Arm I

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (1)

Saint Luke's Radiation Oncology Network

Dublin, 6, Ireland

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast

Interventions

Radiotherapy, Conformal; Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Pierre Thirion, MD

  Saint Luke's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: October 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IE (1)