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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01294 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (IOERT boost) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electron Beam Therapy | Radiation | Undergo IOERT boost |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Dose-limiting 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. | Up to 30 days after surgery and IOERT boost |
| 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. | At 1 year from the end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 3 years |
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Inclusion Criteria:
Pathologically proven diagnosis of breast cancer
Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Bazan, MD, MS | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States | ||
| University Hospitals |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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Three participants enrolled in the study but were deemed not eligible before starting the study procedures.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2025 |
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| Lumpectomy | Procedure | Undergo lumpectomy |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
|
| Radiation Therapy | Radiation | Undergo whole breast radiation therapy |
|
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| Reconstructive Surgery | Procedure | Undergo oncoplastic reconstruction |
|
|
| 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 |
| Up to 3 years after completion of radiation therapy |
| 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 | Up to 3 years after completion of radiation therapy |
| Rate of Ipsilateral Breast Tumor Recurrence | The exact binomial confidence interval for the rate will be calculated. | At 5 years |
| Cleveland |
| Ohio |
| 44106 |
| United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Centre Hospitalier de I'Universite de Montreal | Québec | Montreal | H2X0C1 | Canada |
| Received IORT |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Dose-limiting 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. | Only the first 30 participants were analyzed for this outcome. | Posted | Number | Number of Events | Up to 30 days after surgery and IOERT boost |
|
|
| ||||||||||||||||||||||||||
| Primary | 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. | Only participants who underwent IOERT are included for analysis | Posted | Count of Participants | Participants | At 1 year from the end of therapy |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Baseline up to 3 years | Participants | |||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Up to 3 years after completion of radiation therapy | Participants | |||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Up to 3 years after completion of radiation therapy | Participants | |||||||||||||||||||||||||||||||
| Secondary | Rate of Ipsilateral Breast Tumor Recurrence | The exact binomial confidence interval for the rate will be calculated. | Not Posted | At 5 years | Participants |
Up to 5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 5 | 105 | 36 | 105 | 103 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis (SAE) | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
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| Atrial fibrillation (SAE) | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Aortic valve replacement, coronary artery bypass grafting, and maze ablation (SAE) | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Duodenal Hemorrhage | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| non-cardiac chest pain | General disorders and administration site conditions | CTCAE v.5.0 | Systematic Assessment |
| |
| Appendicitis (SAE) | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Localized edema and erythema treated as cellulitis, bilateral lower extremities (SAE) | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Lung Infection, pneumonia | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Skin infection, right arm cellulitis, intermittent | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Urinary Tract Infection (SAE) | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Dermatitis Radiation | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Fracture, closed fracture tibia and fibula | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Fracture-nondisplaced sternal fracture | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
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| Hyponatremia (SAE) | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, left knee bursitis (SAE) | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Headache (SAE) | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Syncope (SAE) | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
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| Reproductive system and breast disorders - other, menstrual cramps | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hysterectomy/BSO due to heavy menstrual bleeding and dysmenorrhea (SAE) | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Epistaxis, intermittent | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Breast Retraction | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Dry skin, whole body | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Paronychia on finger | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Skin hypopigmentation, left breast | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Surgical and medical procedure, intracranial hypertension | Surgical and medical procedures | CTCAE v.5.0 | Systematic Assessment |
| |
| Surgical and medical procedures - Other, Hysterectomy, BSO (elective surgery) | Surgical and medical procedures | CTCAE v.5.0 | Systematic Assessment |
| |
| Surgical and medical procedures, Right shoulder reverse total shoulder arthroplasty (SAE) | Surgical and medical procedures | CTCAE v.5.0 | Systematic Assessment |
| |
| Arterial thromboembolism | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hematoma, left breast | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | CTCAE v.5.0 | Systematic Assessment |
| |
| Localized edema, bilateral breasts | General disorders and administration site conditions | CTCAE v.5.0 | Systematic Assessment |
| |
| Localized edema, left breast | General disorders and administration site conditions | CTCAE v.5.0 | Systematic Assessment |
| |
| Localized edema, right breast | General disorders and administration site conditions | CTCAE v.5.0 | Systematic Assessment |
| |
| fatigue | General disorders and administration site conditions | CTCAE v.5.0 | Systematic Assessment |
| |
| Upper respiratory infection, COVID-19 | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Dermatitis Radiation | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Dermatitis radiation, left breast | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Dermatitis radiation, right breast | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Erythema | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
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| Weight gain | Investigations | CTCAE v.5.0 | Systematic Assessment |
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| Weight loss | Investigations | CTCAE v.5.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fibrosis | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fibrosis deep connective tissue | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fibrosis deep connective tissue, left breast | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fibrosis deep connective tissue, right breast | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Joint range of motion decreased, right shoulder | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
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| Breast Pain | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Breast atrophy | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Breast atrophy, left breast | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
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| Breast atrophy, right | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
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| Breast atrophy, right breast | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Breast pain, bilateral | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
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| Breast pain, left | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
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| Breast pain, left breast | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
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| Breast pain, right breast | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
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| Dyspareunia | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
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| Vaginal dryness | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Skin hyperpigmentation, left breast | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Skin hyperpigmentation, right breast | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Skin hypopigmentation, left breast | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Skin induration, left breast | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Hot Flashes | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
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| Hot flashes | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
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| hot flashes | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sachin Jhawar | The Ohio State University Comprehensive Cancer Center | (614) 688-7040 | Sachin.Jhawar@osumc.edu |
| May 7, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2025 | May 7, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| D019651 | Plastic Surgery Procedures |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
|