Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer

NCT00647582 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000588774P30CA015083MCS0661681-02
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy during and after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects of giving radiation therapy during and after lumpectomy and to see how well it works in treating women with stage I or stage II breast cancer.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (6)

• Feasibility

• Acute tolerability

• Local tumor control rate

• Distant tumor control rate

• Long-term side effects

• Cosmetic outcome

Interventions

adjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

intraoperative radiation therapy RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed primary invasive breast carcinoma, meeting the following criteria: * Stage I or II disease (T1-T2, N0, M0) * Tumor pathologically determined to be ≤ 5 cm in diameter * Single, discrete, well-defined primary tumor * No multicentric disease and/or diffuse malignant appearing microcalcifications * Any microcalcifications must be focal * Specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications * No axillary lymph node involvement * Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling * Must have pathologically negative surgical margins * No evidence of metastatic breast cancer * Hormone receptor status not specified PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Menopausal status not specified * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy PRIOR CONCURRENT THERAPY: * No prior irradiation to the area of planned radiation field * Concurrent hormone therapy allowed

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• William W. Wong, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: March 31, 2008
• Study Start: October 1, 2002
• Primary Completion: June 1, 2005
• Study Completion: December 21, 2013
• Last Updated: March 21, 2018

Record last verified: 2016-04