Breast CancerPhase 2NCT00581529
Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy
A Phase 2 study testing IMRT in people with Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This is a phase I- II feasibility study for delivering partial breast irradiation (PBI) in selected patients with early stage, lymph node negative, breast cancer after breast-conserving surgery using accelerated Intensity Modulated Radiotherapy (IMRT). Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Aug 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with unifocal histologically proven breast cancer, with or without calcifications in mammogram.
- DCIS (Ductal carcinoma in situ) (Tis, Stage 0)
- Non-lobular infiltrating carcinoma, maximum of 2 cm in diameter. (T1, Stage I)
- The patient was operated on and the tumor was excised with lumpectomy
- The tumor is reported with negative margins >3 mm, as per our hospital protocol.
- For invasive carcinoma, axillary lymph nodes are negative by sentinel lymph node (SLN) mapping and biopsy or by formal axillary lymph node dissection.
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- The patient is over 40 years old with life expectancy of at least 5 years
- Karnofsky status must be at least 70. See appendix I.
- Pre- and post-menopausal women are eligible for entry.
- The patient must be aware of the neoplastic nature of her disease and must be willing to consent after being informed of the potential benefits, side effects and risks of radiotherapy. Institutional Review Board approval of this protocol and a consent form is required.
Who cannot join
- No concurrent or neoadjuvant chemotherapy is allowed. Patient is permitted to be treated with chemotherapy or hormone therapy only after completion of the radiation treatment.
- Patients with diffuse calcifications, multifocal or multicentric disease, lymph-vascular invasion are excluded.
- Patients cannot participate if there is extensive LCIS (Lobular carcinoma in situ) in specimen or extensive DCIS.
- Patients are excluded if systemic disease is present or the patient has been irradiated to the ipsilateral breast or the chest wall.
- Patients who are carriers of BRCA 1/2 mutations or at high risk for hereditary breast cancer due to strong family history (more than one pre-menopausal family member with breast cancer or any ovarian cancer) are excluded because of the increased potential for in-breast recurrence elsewhere in the breast in the absence of whole breast radiotherapy.
- Patients with scleroderma, or systemic or discoid lupus are excluded due to the potential for significant radiotherapy associated toxicity.
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- Pregnant woman cannot participate in the study.
- Patients who have serious medical problems which would limit survival to <5 years or a psychiatric condition which would prevent informed consent cannot participate.
- Patients who are unable to lie on their back and raise their arms above their heads in the treatment planning position for radiotherapy are excluded.
- Patients that have mammographically occult disease are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109-5010
About this study
Official title: Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy in Early Stage Breast Cancer After Breast-Conserving Surgery
This is a phase I- II feasibility study for delivering partial breast irradiation (PBI) in selected patients with early stage, lymph node negative, breast cancer after breast-conserving surgery using accelerated Intensity Modulated Radiotherapy (IMRT).
Read the detailed description
This is a non-randomized Phase I-II feasibility study of partial breast irradiation with accelerated IMRT technique. In this study, patients will be eligible if the estimated risk of breast cancer elsewhere in the breast (beyond the tumor bed) is low. The radiation treatment will be available to women who are older than 40 years, have a DCIS (Ductal carcinoma in situ) or T1, N0, M0, (AJCC classification, version 6.0), non-lobular infiltrating carcinoma treated with breast-conserving surgery.
Patients will undergo a pre-treatment planning free breathing CT with 5mm cuts in the treatment position, on a breast board, with both arms extended above their head that will be used to plan the traditional two field (tangent) plan. An Active Breathing Control (ABC) device will be used to minimize target motion due to breathing during a second CT scan. The lumpectomy cavity will be identified and delineated, and margins of approximately 1.5 cm in three dimensions will be used to allow for subclinical tumor extension and daily set-up error. The organs at risk (heart, lungs, contralateral breast) will be contoured on both CT scans. An inverse planning system and optimization tools will be employed in order to achieve the best IMRT plan (to minimize the dose to the heart, lungs and contralateral breast), that will be compared to the two field plan. If the IMRT plan is shown to be the optimal one, in terms of doses to organs at risk, then the patient will be enrolled in the protocol and will proceed with the treatment. Treatment will start approximately two weeks after the planning CT is obtained. All patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
- Conditions
- Breast Cancer
- Being tested
- IMRT
- Keywords
- breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRTRadiation
Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | IMRT (Intensity-modulated Radiation Therapy), 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy. Receives: Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Local Control at 5 Years
The primary objective was to determine the rate of local control (the arrest of cancer growth at the site of origin) of cancer in the treated breast at 5 years following breast-conserving surgery and partial breast radiotherapy using IMRT.
Measured: 5 years
Percentage of Participants That Experience Cosmetic Adverse Events (AEs)
The primary outcome was to determine the rate of acute cosmetic adverse events and late cosmetic adverse events at follow-up visits over 5 years. To determine the rate of adverse events, the percentage of participants experiencing no cosmetic AEs, at least 1 grade 1 toxicity, at least 1 grade 2 toxicity, and at least 1 grade 3 toxicity were calculated.
Measured: 5 years
Secondary outcomes (2)
Dosimetric and Volumetric Differences Between Treatment Plans for Partial Breast Irradiation and Other Treatment Planning Methods
Dosimetric and volumetric differences between treatment plans for partial breast irradiation and other treatment planning methods for the target (partial breast) and organs at risk (e.g. heart, ipsilateral lung, contralateral breast)a subset of 20.
Measured: not specific
Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis
One of the studies secondary outcomes was to evaluate the impact of short term accelerated partial breast radiation therapy on cosmetic results. To determine the association between dosimetric factors and cosmesis, the mean percentage of prescription dose received to WBV (Whole breast volume: corresponding region typically encompassed by traditional tangent fields) was compared among participants who developed fair/poor (F/P) cosmetic outcomes (unacceptable cosmesis) and participants who maintained excellent/good (E/G) cosmetic outcomes (acceptable cosmesis).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startNov 2004
- Primary completionOct 2010
- Study completionAug 2014
Why it stopped: The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori J Pierce, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581529
- Sponsor's protocol ID
- UMCC 2004.020
- Other IDs
- IRB #2004-0459 & HUM 44980
- Status last verified
- Sep 2017
- First submitted
- 20 Dec 2007
- Last updated
- 31 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy in Early Stage Breast Cancer After Breast-Conserving Surgery
- ClinicalTrials.gov ID
- NCT00581529
- Acronym / sponsor ID
- UMCC 2004.020
- Conditions
- Breast Cancer
- Keywords
- breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Oct 2010 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 28 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I- II feasibility study for delivering partial breast irradiation (PBI) in selected patients with early stage, lymph node negative, breast cancer after breast-conserving surgery using accelerated Intensity Modulated Radiotherapy (IMRT).
Detailed description
This is a non-randomized Phase I-II feasibility study of partial breast irradiation with accelerated IMRT technique. In this study, patients will be eligible if the estimated risk of breast cancer elsewhere in the breast (beyond the tumor bed) is low. The radiation treatment will be available to women who are older than 40 years, have a DCIS (Ductal carcinoma in situ) or T1, N0, M0, (AJCC classification, version 6.0), non-lobular infiltrating carcinoma treated with breast-conserving surgery.
Patients will undergo a pre-treatment planning free breathing CT with 5mm cuts in the treatment position, on a breast board, with both arms extended above their head that will be used to plan the traditional two field (tangent) plan. An Active Breathing Control (ABC) device will be used to minimize target motion due to breathing during a second CT scan. The lumpectomy cavity will be identified and delineated, and margins of approximately 1.5 cm in three dimensions will be used to allow for subclinical tumor extension and daily set-up error. The organs at risk (heart, lungs, contralateral breast) will be contoured on both CT scans. An inverse planning system and optimization tools will be employed in order to achieve the best IMRT plan (to minimize the dose to the heart, lungs and contralateral breast), that will be compared to the two field plan. If the IMRT plan is shown to be the optimal one, in terms of doses to organs at risk, then the patient will be enrolled in the protocol and will proceed with the treatment. Treatment will start approximately two weeks after the planning CT is obtained. All patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: IMRTIMRT (Intensity-modulated Radiation Therapy), 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient with unifocal histologically proven breast cancer, with or without calcifications in mammogram.
- DCIS (Ductal carcinoma in situ) (Tis, Stage 0)
- Non-lobular infiltrating carcinoma, maximum of 2 cm in diameter. (T1, Stage I)
- The patient was operated on and the tumor was excised with lumpectomy
- The tumor is reported with negative margins >3 mm, as per our hospital protocol.
Key exclusion criteria (10 listed)
- No concurrent or neoadjuvant chemotherapy is allowed. Patient is permitted to be treated with chemotherapy or hormone therapy only after completion of the radiation treatment.
- Patients with diffuse calcifications, multifocal or multicentric disease, lymph-vascular invasion are excluded.
- Patients cannot participate if there is extensive LCIS (Lobular carcinoma in situ) in specimen or extensive DCIS.
- Patients are excluded if systemic disease is present or the patient has been irradiated to the ipsilateral breast or the chest wall.
- Patients who are carriers of BRCA 1/2 mutations or at high risk for hereditary breast cancer due to strong family history (more than one pre-menopausal family member with breast cancer or any ovarian cancer) are excluded because of the increased potential for in-breast recurrence elsewhere in the breast in the absence of whole breast radiotherapy.
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 |
|---|---|---|
| IMRTPatients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy. | Radiation | Radiotherapy |
Primary outcome
Rate of Local Control at 5 Years
Time frame: 5 years
The primary objective was to determine the rate of local control (the arrest of cancer growth at the site of origin) of cancer in the treated breast at 5 years following breast-conserving surgery and partial breast radiotherapy using IMRT.
Percentage of Participants That Experience Cosmetic Adverse Events (AEs)
Time frame: 5 years
The primary outcome was to determine the rate of acute cosmetic adverse events and late cosmetic adverse events at follow-up visits over 5 years. To determine the rate of adverse events, the percentage of participants experiencing no cosmetic AEs, at least 1 grade 1 toxicity, at least 1 grade 2 toxicity, and at least 1 grade 3 toxicity were calculated.
2 secondary outcomes
Dosimetric and Volumetric Differences Between Treatment Plans for Partial Breast Irradiation and Other Treatment Planning Methods
Time frame: not specific
Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lori J Pierce, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMRT in people with Breast Cancer, run by University of Michigan Rogel Cancer Center 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 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 31 Oct 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Local Control at 5 Years (time frame: 5 years). The study lists 2 primary outcomes in all. 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 31 Oct 2017.