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

Primary Purpose

Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Electron Beam Therapy
Lumpectomy
Quality-of-Life Assessment
Questionnaire Administration
Radiation Therapy
Reconstructive Surgery
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IA Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina
  • University Hospitals
  • Ohio State University Comprehensive Cancer CenterRecruiting
  • Avera Cancer InstituteRecruiting
  • Centre Hospitalier de I'Universite de Montreal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (IOERT boost)

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0
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.
Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales
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

Change in self-reported cosmesis using the BCTOS
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.
Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs
physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs
Quality of life assessed by Breast Cancer Treatment Outcome Scale
determine the rate of surgical complications necessitating hospital readmission or return to the operating room within 30 days of surgery + IOERT
Rate of ipsilateral breast tumor recurrence
The exact binomial confidence interval for the rate will be calculated.

Full Information

First Posted
October 6, 2016
Last Updated
April 7, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02927912
Brief Title
Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (IOERT boost)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Electron Beam Therapy
Other Intervention Name(s)
photon beam radiation therapy
Intervention Description
Undergo IOERT boost
Intervention Type
Procedure
Intervention Name(s)
Lumpectomy
Other Intervention Name(s)
Lumpectomy of Breast, Partial Mastectomy
Intervention Description
Undergo lumpectomy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RADIATION, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo whole breast radiation therapy
Intervention Type
Procedure
Intervention Name(s)
Reconstructive Surgery
Other Intervention Name(s)
Reconstruction
Intervention Description
Undergo oncoplastic reconstruction
Primary Outcome Measure Information:
Title
Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0
Description
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.
Time Frame
Up to 30 days after surgery and IOERT boost
Title
Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales
Description
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.
Time Frame
At 1 year from the end of therapy
Secondary Outcome Measure Information:
Title
Change in self-reported cosmesis using the BCTOS
Description
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.
Time Frame
Baseline up to 3 years
Title
Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs
Description
physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs
Time Frame
Up to 3 years after completion of radiation therapy
Title
Quality of life assessed by Breast Cancer Treatment Outcome Scale
Description
determine the rate of surgical complications necessitating hospital readmission or return to the operating room within 30 days of surgery + IOERT
Time Frame
Up to 3 years after completion of radiation therapy
Title
Rate of ipsilateral breast tumor recurrence
Description
The exact binomial confidence interval for the rate will be calculated.
Time Frame
At 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Bazan, MD, MS
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Completed
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin Jhawar, MD
Phone
614-688-7371
Email
Sachin.Jhawar@osumc.edu
First Name & Middle Initial & Last Name & Degree
Sachin Jhawar, MD
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl Ageton, RN
Phone
605-322-3095
Email
cheryl.ageton@avera.org
First Name & Middle Initial & Last Name & Degree
Kyle Arneson, MD
Facility Name
Centre Hospitalier de I'Universite de Montreal
City
Québec
State/Province
Montreal
ZIP/Postal Code
H2X0C1
Country
Canada
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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