Invasive Ductal Breast CancerNCT01960803
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)
A study testing Intraoperative Electron Radiotherapy in people with Invasive Ductal Breast Cancer and Carcinoma Breast Stage I, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer. Read more about this study
- Who is it for?
- Ages 50 to 95 years, women only
- Conditions the study is for
- Invasive Ductal Breast Cancer, Carcinoma Breast Stage I
- What is being tested?
- Intraoperative Electron Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2013to 5 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
- Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
- Peri or post-menopausal women age > 50, defined as women who have experienced no menstrual period in the past 6 months or more
- BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history]
- Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of Tis or T1 (AJCC criteria)
- Grade 1, 2, or 3 acceptable
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- Associated LCIS is allowed
- Pure DCIS allowed if <2.5 cm, low to intermediate nuclear grade and resected margins negative at > 3 mm (per ASTRO criteria)
- Estrogen receptor (ER) status of positive
- Patient has clear margins >2 mm on gross pathologic examination
- Patient is node-negative, defined as N0 (i-) or N0 (i+)
- Patient must be deemed functionally and mentally competent to understand and sign the informed consent
- Neoadjuvant hormonal therapy is allowed if all other ASTRO suitable criteria have been met prior to onset of hormonal therapy
Who cannot join
- Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years
- Immunocompromised status
- Pregnancy
- Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
- Breast cancer that involves the skin or chest wall, locally advanced breast cancer
- Invasive lobular carcinoma
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- Evidence of lymphovascular invasion (LVI)
- Invasive carcinoma with extensive intraductal component (EIC)
- Neoadjuvant chemotherapy
- Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
- Someone who is not a candidate for breast conserving management, i.e., prior whole breast radiation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
About this study
Official title: Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer
The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.
Read the detailed description
Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire.
Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.
- Being tested
- Intraoperative Electron Radiotherapy
- Keywords
- Stage I Breast Carcinoma
- Medical subject headings
- Carcinoma, Ductal, Breast, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Electron RadiotherapyRadiation
Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.
| Study group | Role | What they receive |
|---|---|---|
| IOERT arm | Experimental | Intraoperative electron radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on a mobile self-shielded magnetron-driven X-band linear accelerator specifically developed for use in the operating room. This machine produces megavoltage electron beams of energy ranging between 4 and 12 MeV. The radiation is delivered from the device to the tumor bed through an attached applicator. A single dose of 21 Gy calculated to the 90% depth posterior to the tumor bed will be administered and will last approximately 2.5 minutes. Receives: Radiation: Intraoperative Electron Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate change over time on the incidence of local and distance recurrence rates.
Subjects will be followed for recurrence rates at one month, three months, six months, twelve months, and then annually for up to 10 years. This will include: history and physical exam, as well as radiographic images at physician discretion and per study protocol.
Measured: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
Secondary outcomes (1)
To evaluate changes in the short-term and long-term side effects related to IOERT
Assessment of the overall patient satisfaction related to the therapy and cosmetic outcome. Cosmesis will be scored by both the physician and patient using the RTOG cosmesis rating system at one month, three months, six months, twelve months, and 24 months. The secondary outcome measure will only take place in the first two years of the 10 year time frame for patient follow up. After 24 month evaluations, patients will only be followed for incidence of local and distance recurrence rates.
Measured: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study start1 May 2013
- Primary completion3 Jun 2019
- Study completion5 Jul 2019
Why it stopped: IOERT is no longer an experimental treatment and was now offered as SOC to patients experiencing IBC. As this therapy is being offered to them regardless of study participation at numerous institutions across the country.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Ductal Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Krueger, MD FACS, Principal investigator, Advocate Health Care - Advocate Christ Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960803
- Sponsor's protocol ID
- ACI-001
- Status last verified
- Jul 2024
- First submitted
- 25 Sep 2013
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT01960803
- Acronym / sponsor ID
- ACI-001
- Keywords
- Stage I Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IOERT is no longer an experimental treatment and was now offered as SOC to patients experiencing IBC. As this therapy is being offered to them regardless of study participation at numerous institutions across the country.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.
Detailed description
Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire.
Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOERT arm | Experimental | Radiation: Intraoperative Electron RadiotherapyIntraoperative electron radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on a mobile self-shielded magnetron-driven X-band linear accelerator specifically developed for use in the operating room. This machine produces megavoltage electron beams of energy ranging between 4 and 12 MeV. The radiation is delivered from the device to the tumor bed through an attached applicator. A single dose of 21 Gy calculated to the 90% depth posterior to the tumor bed will be administered and will last approximately 2.5 minutes. |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
- Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
- Peri or post-menopausal women age > 50, defined as women who have experienced no menstrual period in the past 6 months or more
- BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history]
- Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of Tis or T1 (AJCC criteria)
Key exclusion criteria (11 listed)
- Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years
- Immunocompromised status
- Pregnancy
- Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
- Breast cancer that involves the skin or chest wall, locally advanced breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Electron RadiotherapyIntraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. | Radiation | IOERT arm |
Primary outcome
To evaluate change over time on the incidence of local and distance recurrence rates.
Time frame: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
Subjects will be followed for recurrence rates at one month, three months, six months, twelve months, and then annually for up to 10 years. This will include: history and physical exam, as well as radiographic images at physician discretion and per study protocol.
1 secondary outcome
To evaluate changes in the short-term and long-term side effects related to IOERT
Time frame: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Krueger, MD FACS principal investigator
Advocate Health Care - Advocate Christ Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Electron Radiotherapy in people with Invasive Ductal Breast Cancer and Carcinoma Breast Stage I, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate change over time on the incidence of local and distance recurrence rates. (time frame: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.