Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02927912
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Jose Bazan, Ohio State University Comprehensive Cancer Center

Brief Summary:
This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.

Condition or disease Intervention/treatment Phase
Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Radiation: Electron Beam Therapy Procedure: Lumpectomy Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Therapy Procedure: Reconstructive Surgery Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the rate of grade 3 breast fibrosis at 1 year in women undergoing lumpectomy with oncoplastic reconstruction and immediate intraoperative electron radiotherapy boost followed by adjuvant whole breast radiotherapy.

SECONDARY OBJECTIVES:

I. To determine the rate of 5 year ipsilateral breast tumor recurrence rate. II. To determine the change in self-reported cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire.

III. To evaluate physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs.

OUTLINE:

Patients undergo standard of care lumpectomy and then undergo 1 fraction of intraoperative electron beam radiation therapy (IOERT) boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.

After completion of study treatment, patients are followed up at 1 month, 6 months, 1 year, and every year thereafter for 5 years.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer
Actual Study Start Date : March 23, 2017
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (IOERT boost)
Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
Radiation: Electron Beam Therapy
Undergo IOERT boost
Other Name: photon beam radiation therapy

Procedure: Lumpectomy
Undergo lumpectomy
Other Names:
  • Lumpectomy of Breast
  • Partial Mastectomy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Radiation Therapy
Undergo whole breast radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RADIATION
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

Procedure: Reconstructive Surgery
Undergo oncoplastic reconstruction
Other Name: Reconstruction




Primary Outcome Measures :
  1. Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0 [ Time Frame: Up to 30 days after surgery and IOERT boost ]
    If 4 or more complications in the first 10 patients, 7 or more out of the first 20 patients or 9 or more out of 30 patients are observed, then the study will be deemed not safe to continue. Summary statistics will be used to report all complications.

  2. Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales [ Time Frame: At 1 year from the end of therapy ]
    The proportion of patients with an overall response rate of grade 3 fibrosis at 1 year from the end of therapy along with the exact binomial confidence interval for the rate will be calculated.


Secondary Outcome Measures :
  1. Change in self-reported cosmesis using the BCTOS [ Time Frame: Baseline up to 3 years ]
    The mean and standard deviation of the self-reported cosmesis using the BCTOS cosmesis scale will be summarized over time. The change over time using a repeated measures model or non-parametric methods, if appropriate, will be examined.

  2. Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs [ Time Frame: Up to 3 years after completion of radiation therapy ]
    physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs

  3. Quality of life assessed by Breast Cancer Treatment Outcome Scale [ Time Frame: Up to 3 years after completion of radiation therapy ]
    determine the rate of surgical complications necessitating hospital readmission or return to the operating room within 30 days of surgery + IOERT

  4. Rate of ipsilateral breast tumor recurrence [ Time Frame: At 5 years ]
    The exact binomial confidence interval for the rate will be calculated.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically proven diagnosis of breast cancer
  • Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer

    • Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician
  • Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup
  • History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry
  • Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
  • Absolute neutrophil count > 1800 cells/cubic mm
  • Platelets >= 75,000 cells/cubic mm
  • Hemoglobin >= 8 g/dL
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry
  • Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
  • Patients must provide study specific informed consent prior to study entry

Exclusion Criteria:

  • Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
  • Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry
  • Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
  • Two or more cancers not resectable through a single lumpectomy incision
  • Bilateral breast cancer
  • Ductal breast carcinoma in situ (DCIS) only
  • Non-epithelial breast malignancies such as sarcoma/lymphoma
  • Male breast cancer
  • Paget's disease of the nipple
  • Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields
  • Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
  • Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927912


Contacts
Layout table for location contacts
Contact: The Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu
Contact: Sohyun McElroy 614-685-7050 sohyun.mcelroy@osumc.edu

Locations
Layout table for location information
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Zahra Mahbooba, BA, CCRC    984-974-8744    zahra_mahbooba@med.unc.edu   
Principal Investigator: Gaorav Gupta, MD, PhD         
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Jose G. Bazan, MD, MS    614-688-7371    jose.bazan2@osumc.edu   
Principal Investigator: Jose G. Bazan         
United States, South Dakota
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Cheryl Ageton, RN    605-322-3095    cheryl.ageton@avera.org   
Principal Investigator: Kyle Arneson, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Jose Bazan, MD, MS Ohio State University Comprehensive Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: Jose Bazan, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02927912     History of Changes
Other Study ID Numbers: OSU-16106
NCI-2016-01294 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases