Breast CancerNCT01646346
4D Image-Guided Partial Breast Radiation in Stage 0 and l Breast Cancer
A study testing 4D Conformal Image-Guided Partial Breast RT in people with Breast Cancer, run by Yale University at 1 site in United States.
Trial summary
The Purpose of this study is to evaluate the feasibility of using image guidance and four-dimensional computed tomography to reduce the volume of non target breast tissue that is treated with accelerated partial breast irradiation via the external beam technique. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 4D Conformal Image-Guided Partial Breast RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2012to 17 Jul 2017
- Phase
- Interventional
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.
- Patient must be > 50 years old.
- The patient should have a life expectancy of at least two years with a karnofsky performance status > 70.
- The patient must have stage 0 or I breast cancer.
- On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
- Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted.
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- Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 2 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 2 cm or less.)
- Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is NOT required for patients with DCIS.
- The patient must have simulation within 8 weeks/56 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).
- Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to enrollment. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
- Chemotherapy is permitted if planned for ≥ 2 weeks after radiation.
- Urine pregnancy test must be performed and be negative on all women younger than 60 who have not had a tubal ligation, oophorectomy, or hysterectomy.
- Separate incisions for the lumpectomy and sentinel node biopsy should be present. Use of only one incision will typically result in a contiguous cavity with the tumor bed and the sentinel node sampling, and inability of the radiation oncologist to delineate the tumor bed from the sentinel node bed.
- The patient must have a cavity which is able to be targeted with external beam APBI, either through surgical clip placement, or CVS 3 or higher. The cavity to whole breast ratio must be 30% or less.
Who cannot join
- Men are not eligible for this study as men are not breast conservation candidates.
- T0, T2 (> 2.0 cm), T3, node positive, stage III or IV breast cancer.
- Any positive axillary nodes.
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.
- Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
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- Proven multicentric carcinoma in more than one quadrant or separated by more than 2 centimeters.
- Paget's disease of the nipple.
- History of invasive breast cancer or DCIS in the same breast.
- Surgical margins that cannot be microscopically assessed or are less then 2 mm.
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
- Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the treating physician, would preclude the patient from meeting the study requirements.
- Patients with coexisting medical conditions in whom life expectancy is < 2 years.
- Patients with skin involvement, regardless of tumor size.
Trial locations and contacts
1 site in 1 country.
United States1 site
Smilow Cancer Hospital Care Center, Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: A Pilot Study of Four-Dimensional Conformal Image Guided Accelerated Partial Breast Irradiation In The Treatment Of Stage 0 and l Breast Cancer
The Purpose of this study is to evaluate the feasibility of using image guidance and four-dimensional computed tomography to reduce the volume of non target breast tissue that is treated with accelerated partial breast irradiation via the external beam technique.
Read the detailed description
This is a pilot study enrolling about 30 patients to evaluate the feasibility of using 4D CT and daily image guidance in Accelerated Partial Breast Irradiation (APBI) to decrease set-up error and individualized planning target volumes to limit the non-target breast tissue dose. The two specific breasts constraints which shall be decreased are the V50 (percent volume of breast receiving 50% of the prescribed dose) and the V100 (percent volume of breast receiving 100% of the prescribed dose). The goal will be to decrease these to 45% and 23.5% respectively, which is down 33% from the NSABP B39 standard of 60% and 35%.
- Conditions
- Breast Cancer
- Being tested
- 4D Conformal Image-Guided Partial Breast RT
- Keywords
- Breast Cancer, Radiation for Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D Conformal Image-Guided Partial Breast RTRadiation
Also called 4D conformal image guided radiation therapy
External beam partial breast radiation to target a portion of the breast twice a day for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| 4D Conformal Image-Guided Partial Breast RT | Experimental | This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days. Receives: Radiation: 4D Conformal Image-Guided Partial Breast RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Reduction in Incidental Radiation
Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.
Measured: 5 day
Secondary outcomes (6)
Cosmesis by Patient Report
This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.
Measured: Within no more than 8 weeks of surgery, but prior to the start of radiation
Cosmesis by Patient Report
This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.
Measured: 1 year post treatment
Cosmesis by Patient Report
This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.
Measured: 3 year post treatment
Cosmesis by Medical Doctor Report
Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.
Measured: Within no more than 8 weeks of surgery, but prior to the start of radiation
Cosmesis by Medical Doctor Report
Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.
Measured: 1 yr post treatment
Cosmesis by Medical Doctor Report
Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.
Measured: 3 yr post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study start10 Jan 2012
- Primary completion17 Jul 2017
- Study completion17 Jul 2017
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.
- More trials run by Yale UniversityThe 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Evans, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646346
- Sponsor's protocol ID
- 1110009173
- Status last verified
- Oct 2018
- First submitted
- 11 Mar 2012
- Last updated
- 23 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Four-Dimensional Conformal Image Guided Accelerated Partial Breast Irradiation In The Treatment Of Stage 0 and l Breast Cancer
- ClinicalTrials.gov ID
- NCT01646346
- Acronym / sponsor ID
- 1110009173
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Radiation for Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 10 Jan 2012 (actual)
- Primary completion
- 17 Jul 2017 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Posted 23 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Purpose of this study is to evaluate the feasibility of using image guidance and four-dimensional computed tomography to reduce the volume of non target breast tissue that is treated with accelerated partial breast irradiation via the external beam technique.
Detailed description
This is a pilot study enrolling about 30 patients to evaluate the feasibility of using 4D CT and daily image guidance in Accelerated Partial Breast Irradiation (APBI) to decrease set-up error and individualized planning target volumes to limit the non-target breast tissue dose. The two specific breasts constraints which shall be decreased are the V50 (percent volume of breast receiving 50% of the prescribed dose) and the V100 (percent volume of breast receiving 100% of the prescribed dose). The goal will be to decrease these to 45% and 23.5% respectively, which is down 33% from the NSABP B39 standard of 60% and 35%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4D Conformal Image-Guided Partial Breast RT | Experimental | Radiation: 4D Conformal Image-Guided Partial Breast RTThis is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.
- Patient must be > 50 years old.
- The patient should have a life expectancy of at least two years with a karnofsky performance status > 70.
- The patient must have stage 0 or I breast cancer.
- On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
Key exclusion criteria (15 listed)
- Men are not eligible for this study as men are not breast conservation candidates.
- T0, T2 (> 2.0 cm), T3, node positive, stage III or IV breast cancer.
- Any positive axillary nodes.
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.
- Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.
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 |
|---|---|---|
| 4D Conformal Image-Guided Partial Breast RTAlso: 4D conformal image guided radiation therapyExternal beam partial breast radiation to target a portion of the breast twice a day for 5 days. | Radiation | 4D Conformal Image-Guided Partial Breast RT |
Primary outcome
Patients With Reduction in Incidental Radiation
Time frame: 5 day
Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.
6 secondary outcomes
Cosmesis by Patient Report
Time frame: Within no more than 8 weeks of surgery, but prior to the start of radiation
Cosmesis by Patient Report
Time frame: 1 year post treatment
Cosmesis by Patient Report
Time frame: 3 year post treatment
Cosmesis by Medical Doctor Report
Time frame: Within no more than 8 weeks of surgery, but prior to the start of radiation
Cosmesis by Medical Doctor Report
Time frame: 1 yr post treatment
Cosmesis by Medical Doctor Report
Time frame: 3 yr post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- 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.
Suzanne Evans, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D Conformal Image-Guided Partial Breast RT in people with Breast Cancer, run by Yale University 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 14 inclusion and 15 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: finished, as of the sponsor's last update on 23 Nov 2018. 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?
Yes. Results are posted in the registry (first posted 23 Nov 2018). 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?
Patients With Reduction in Incidental Radiation (time frame: 5 day). 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 23 Nov 2018.