Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer

NCT00182728 | Completed Results

• 1 other identifier: LCCC 0218
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for invasive breast cancer.

Conditions

Breast Cancer

Keywords

invasive ductal breast carcinoma; stage I breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (4)

• Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician

  Rates of good/excellent cosmesis was evaluated using the following criteria: Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance. Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.

  1 year follow up visit

• Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Patients

  Rates of good/excellent cosmesis was evaluated using the following criteria: Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance. Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.

  1 year follow up visit

• Incidence of Grade 3/4 Toxicity

  Skin and subcutaneous toxicity were graded by a radiation oncologist according to the common terminology criteria for adverse events version 3.0. Toxicities directly, probably, or possibly related to the radiation were included. Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event (AE) based on this general guideline: Grade 1 Mild Adverse Event Grade 2 Moderate Adverse Event Grade 3 Severe Adverse Event Grade 4 Life-threatening or disabling Adverse Event Grade 5 Death related to Adverse Event

  3 months

• Ipsilateral Breast Recurrence

  Percentage of participants who experienced a ipsilateral breast event (tumor bed recurrence versus elsewhere in breast).

  5 years

Secondary Outcomes (3)

• Association of Phosphorylated Epidermal Growth Factor Receptor (EGFR) , Human Epidermal Growth Factor Receptor 2 (HER2), p44/42 Mitogen-activated Protein Kinase (MAPK), and Protein Kinase B (Akt) in Breast Tumors and Normal Tissue Before and After IORT

  3 months

• Association of Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells (NFkB) Expression in Tumor and Normal Tissue Before and After IORT

  3 months

• Association of Nuclear p53 Expression in Tumor and Normal Tissue Before and After IORT

  3 months

Study Arms (1)

Intraoperative Radiation Arm

EXPERIMENTAL

Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.

Procedure: surgery; Procedure: therapy; Radiation: radiation therapy

Interventions

surgery PROCEDURE

conventional

Intraoperative Radiation Arm

therapy PROCEDURE

neoadjuvant

Intraoperative Radiation Arm

radiation therapy RADIATION

intraoperative radiation therapy

Intraoperative Radiation Arm

Eligibility Criteria

• Age: 48 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed primary invasive ductal carcinoma of the breast * Tumor size ≤ 3 cm * No extensive intraductal component * Tumor must not be attached to the skin, underlying muscle, or chest wall * Candidate for breast-conserving therapy, as determined by the surgical and radiation oncologist * Tumor amenable to segmental mastectomy (i.e., lumpectomy) * No bilateral breast cancer * No clinical or radiographic multifocal disease not amenable to single segmental mastectomy * Patients with \> 1 tumor mass in the same breast must have only 1 mass that is histologically malignant AND all other masses must be proven histologically benign * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 48 and over Sex * Female Menopausal status * Not specified Performance status * 0-2 Life expectancy * At least 5 years Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant * Fertile patients must use effective contraception * No collagen vascular disease * No medical condition that would preclude surgery * Other prior malignancy allowed provided the following criteria are met: * Patient has undergone potential curative therapy for all prior malignancies * There is no evidence of any prior malignancy within the past 5 years * Patient is deemed to be at low risk for recurrence of prior malignancy, as determined by the treating physician PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for this malignancy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the breast Surgery * No breast implants

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Related Publications (5)

• Ollila DW, Klauber-DeMore N, Tesche LJ, Kuzmiak CM, Pavic D, Goyal LK, Lian J, Chang S, Livasy CA, Sherron RF, Sartor CI. Feasibility of breast preserving therapy with single fraction in situ radiotherapy delivered intraoperatively. Ann Surg Oncol. 2007 Feb;14(2):660-9. doi: 10.1245/s10434-006-9154-1.

  PMID: 17091330 BACKGROUND

• Stitzenberg KB, Klauber-Demore N, Chang XS, Calvo BF, Ollila DW, Goyal LK, Meyers MO, Kim HJ, Tepper JE, Sartor CI. In vivo intraoperative radiotherapy: a novel approach to radiotherapy for early stage breast cancer. Ann Surg Oncol. 2007 Apr;14(4):1515-6. doi: 10.1245/s10434-006-9152-3.

  PMID: 17235715 BACKGROUND

• Kimple RJ, Klauber-DeMore N, Kuzmiak CM, Pavic D, Lian J, Livasy CA, Chiu WM, Moore DT, Sartor CI, Ollila DW. Local control following single-dose intraoperative radiotherapy prior to surgical excision of early-stage breast cancer. Ann Surg Oncol. 2011 Apr;18(4):939-45. doi: 10.1245/s10434-010-1392-6.

  PMID: 21061074 RESULT

• Vanderwalde NA, Jones EL, Kimple RJ, Moore DT, Klauber-Demore N, Sartor CI, Ollila DW. Phase 2 study of pre-excision single-dose intraoperative radiation therapy for early-stage breast cancers: six-year update with application of the ASTRO accelerated partial breast irradiation consensus statement criteria. Cancer. 2013 May 1;119(9):1736-43. doi: 10.1002/cncr.27915. Epub 2013 Jan 29.

  PMID: 23361892 RESULT

• Kimple RJ, Klauber-DeMore N, Kuzmiak CM, Pavic D, Lian J, Livasy CA, Esler L, Moore DT, Sartor CI, Ollila DW. Cosmetic outcomes for accelerated partial breast irradiation before surgical excision of early-stage breast cancer using single-dose intraoperative radiotherapy. Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):400-7. doi: 10.1016/j.ijrobp.2009.10.032. Epub 2010 Apr 13.

  PMID: 20395062 RESULT

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast

Interventions

Surgical Procedures, Operative; Therapeutics; Radiotherapy

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

Results Point of Contact

• Title: Robin V Johnson
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• David Olilla, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 16, 2005
• Study Start: March 18, 2003
• Primary Completion: September 1, 2011
• Study Completion: June 13, 2019
• Last Updated: October 1, 2024
• Results First Posted: June 14, 2017

Record last verified: 2024-09

Locations

US (1)