Breast CancerPhase 2NCT01215162
Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer
A Phase 2 study testing Intra-operative radiation to tumor bed in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost irradiation that is usually given after EBRT. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intra-operative radiation to tumor bed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 2013
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Eligibility:
- Histologically proven primary invasive breast carcinoma.
- Tumor pathologically determined <= 5cm in diameter.
- Single, discrete, well-defined primary tumor.
- Any micro-calcifications must be focal. A specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications.
- Pathologically negative surgical margins.
- Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling.
- ECOG performance status 0-2.
Contraindications:
- Multicentric disease and/or diffuse malignant appearing microcalcifications.
- Evidence of metastatic breast cancer.
- Axillary lymph node involvement.
- Pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy.
- Prior irradiation to the ara of planned radiation field.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
The study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost irradiation that is usually given after EBRT. Data from two centers as well as preliminary data from a randomized trial in Europe suggest that IOERT boost is well tolerated and efficacious. In our study, patients will undergo standard lumpectomy and sentinel lymph node sampling or axillary dissection. After the lumpectomy, IOERT of 10 Gy will be delivered in a single fraction to the tumor bed by a mobile electron machine in the operating room. EBRT to the whole breast will be administered once the surgical wound has healed adequately. The primary objective is to determine the feasibility and acute patient tolerance to IOERT and EBRT after lumpectomy. Secondary objectives include assessment of local control and distant control of disease, as well as evaluation of long-term side effects and cosmetic outcome of the treatment.
- Conditions
- Breast Cancer
- Being tested
- Intra-operative radiation to tumor bed
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative radiation to tumor bedRadiation
IOERT is given to the tumor bed. Applicator selection should allow treatment of the tumor bed plus 1-2 cm margin. The surgical incision may need to be enlarged slightly to allow the placement of the appropriate applicator. The use of more than 1 treatment field is discouraged. In order to encompass the entire tumor bed in 1 treatment field, it may be necessary to suture the mammary parenchyma loosely so that the lateral margins of the tumor bed are brought into apposition. Electron energy used for the treatment. If the tumor bed can be flattened and encompassed by an applicator, 6 MeV electron is recommended. Use of bolus material may be considered to increase the surface dose. If the mammary parenchyma has been brought into apposition by sutures, a higher electron energy may be necessary to allow adequate dose coverage to a depth of 1.0-2.0 cm into the tumor bed. The dose of IOERT is 1000 cGy, prescribed to the 90% isodose line.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | Patients with stage T1/T2No breast cancer receiving breast conserving treatment Receives: Radiation: Intra-operative radiation to tumor bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility and acute patient tolerance of IOERT and EBRT after lumpectomy for patients with stage T1/T2N0M0 breast cancer.
To determine the acute skin reaction, breast edema, pnemonitis, cardiac side effects during radiation using RTOG acute toxicity scale
Measured: weekly evaluation during 5 weeks of radiation
Determine the local tumor control and distant tumor control rates for patients with stage T1/T2N0M0 breast cancer.
Measured: every 6 months follow-up for 5 years, then yearly to end in 04/2013
Determine long-term side effects and cosmetic outcome of IOERT to tumor bed and EBRT after lumpectomy for patients with stage T1/T2N0Mo breast cancer.
To determine the late skin reaction, breast edema, pneumonitis, cardiac side effects during radiation using RTOG late toxicity scale
Measured: every 6 months follow-up for 5 years, then yearly to end in 04/2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startJan 2003
- Primary completionJan 2005
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215162
- Sponsor's protocol ID
- 1681-02
- Other IDs
- MCS066
- Status last verified
- Apr 2014
- First submitted
- 7 Aug 2009
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer
- ClinicalTrials.gov ID
- NCT01215162
- Acronym / sponsor ID
- 1681-02
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 6 Oct 2010 (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 study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost irradiation that is usually given after EBRT. Data from two centers as well as preliminary data from a randomized trial in Europe suggest that IOERT boost is well tolerated and efficacious. In our study, patients will undergo standard lumpectomy and sentinel lymph node sampling or axillary dissection. After the lumpectomy, IOERT of 10 Gy will be delivered in a single fraction to the tumor bed by a mobile electron machine in the operating room. EBRT to the whole breast will be administered once the surgical wound has healed adequately. The primary objective is to determine the feasibility and acute patient tolerance to IOERT and EBRT after lumpectomy. Secondary objectives include assessment of local control and distant control of disease, as well as evaluation of long-term side effects and cosmetic outcome of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Radiation: Intra-operative radiation to tumor bedPatients with stage T1/T2No breast cancer receiving breast conserving treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Intra-operative radiation to tumor bedIOERT is given to the tumor bed. Applicator selection should allow treatment of the tumor bed plus 1-2 cm margin. The surgical incision may need to be enlarged slightly to allow the placement of the appropriate applicator. The use of more than 1 treatment field is discouraged. In order to encompass the entire tumor bed in 1 treatment field, it may be necessary to suture the mammary parenchyma loosely so that the lateral margins of the tumor bed are brought into apposition. Electron energy used for the treatment. If the tumor bed can be flattened and encompassed by an applicator, 6 MeV electron is recommended. Use of bolus material may be considered to increase the surface dose. If the mammary parenchyma has been brought into apposition by sutures, a higher electron energy may be necessary to allow adequate dose coverage to a depth of 1.0-2.0 cm into the tumor bed. The dose of IOERT is 1000 cGy, prescribed to the 90% isodose line. | Radiation | Single arm study |
Primary outcome
Determine the feasibility and acute patient tolerance of IOERT and EBRT after lumpectomy for patients with stage T1/T2N0M0 breast cancer.
Time frame: weekly evaluation during 5 weeks of radiation
To determine the acute skin reaction, breast edema, pnemonitis, cardiac side effects during radiation using RTOG acute toxicity scale
Determine the local tumor control and distant tumor control rates for patients with stage T1/T2N0M0 breast cancer.
Time frame: every 6 months follow-up for 5 years, then yearly to end in 04/2013
Determine long-term side effects and cosmetic outcome of IOERT to tumor bed and EBRT after lumpectomy for patients with stage T1/T2N0Mo breast cancer.
Time frame: every 6 months follow-up for 5 years, then yearly to end in 04/2013
To determine the late skin reaction, breast edema, pneumonitis, cardiac side effects during radiation using RTOG late toxicity scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intra-operative radiation to tumor bed in people with Breast Cancer, run by Mayo Clinic 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?
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 3 Apr 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the feasibility and acute patient tolerance of IOERT and EBRT after lumpectomy for patients with stage T1/T2N0M0 breast cancer. (time frame: weekly evaluation during 5 weeks of radiation). The study lists 3 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 3 Apr 2014.