Breast CancerNCT00595062
Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study
A study testing Intra Operative Radiation Therapy (IORT) in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study was started to validate the possibility of administering radiation therapy during surgery to the tissue surrounding the tumor once the tumor has been removed. This surrounding breast tissue is at greater risk for developing breast recurrences. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intra Operative Radiation Therapy (IORT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jul 2013
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Core biopsy or prior open biopsy to establish the diagnosis.
- Over age 60.
- No physical or imaging evidence of multicentricity or multifocality.
- Size equal or less than 2.0 cm radiographically, clinically node negative.
- Patients scheduled for breast conserving surgery
Who cannot join
- Patients younger than 61 years
- Patients with evidence of multicentric or multifocal disease seen on imaging (mammography )
- Patients with a lesion exceeding 2 cm radiographically
- Paget's disease or pure DCIS without invasive ductal carcinoma
- Histotype not inclusive of ductal carcinoma
- Condition precluding radiation therapy
Show all 9Show fewer
- Condition precluding regular follow-up
- Evident dimpling of the skin above the tumor
- Usual contraindications for BCS
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
This study was started to validate the possibility of administering radiation therapy during surgery to the tissue surrounding the tumor once the tumor has been removed. This surrounding breast tissue is at greater risk for developing breast recurrences. This treatment may be as effective as the conventional 5-6week radiation treatment in reducing the risk of further local recurrences after breast-conserving surgery.
Through this study, we would like to confirm that this procedure is a safe alternative to conventional breast radiation, with no additional side effects when compared with the conventional surgery and radiation therapy.
Read the detailed description
This pilot trial will evaluate the feasibility of intra operative radiation therapy (IORT) given in one fraction at the time of wide local excision as the only adjuvant radiation treatment in a group of patients with early-stage invasive breast cancer.
This study will enroll 60 women, older than 60 years of age, with breast cancer not more than 2 cm in size and without evident additional tumoral foci around the tumor or in other areas of the breast. An MSK radiologist will review your mammography to be sure you qualify for this study. You may be asked to undergo additional mammography or other examinations, such as breast ultrasound in order to verify that the tumor is located in a single quadrant of the breast. Some of these procedures are routinely performed in all candidates for conservative breast surgery.
- Conditions
- Breast Cancer
- Being tested
- Intra Operative Radiation Therapy (IORT)
- Keywords
- Breast, Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra Operative Radiation Therapy (IORT)Radiation
Quadrant High Dose Rate Intra Operative Radiation Therapy (IORT)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Radiation: Intra Operative Radiation Therapy (IORT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine tissue tolerance of the breast to a single intraoperative course of radiation.
Measured: 7 years
To establish feasibility of the technique in the operating room.
Measured: 7 years
Secondary outcomes (1)
overall survival
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startOct 2002
- Primary completionJan 2006
- Study completionJul 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 Memorial Sloan Kettering Cancer CenterThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beryl McCormick, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595062
- Sponsor's protocol ID
- 02-101
- Status last verified
- Dec 2015
- First submitted
- 4 Jan 2008
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadrant High Dose Rate Intraoperative Radiation Therapy (IORT) for Early-Stage Breast Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT00595062
- Acronym / sponsor ID
- 02-101
- Conditions
- Breast Cancer
- Keywords
- Breast, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Jan 2008 (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.
This study was started to validate the possibility of administering radiation therapy during surgery to the tissue surrounding the tumor once the tumor has been removed. This surrounding breast tissue is at greater risk for developing breast recurrences. This treatment may be as effective as the conventional 5-6week radiation treatment in reducing the risk of further local recurrences after breast-conserving surgery.
Through this study, we would like to confirm that this procedure is a safe alternative to conventional breast radiation, with no additional side effects when compared with the conventional surgery and radiation therapy.
Detailed description
This pilot trial will evaluate the feasibility of intra operative radiation therapy (IORT) given in one fraction at the time of wide local excision as the only adjuvant radiation treatment in a group of patients with early-stage invasive breast cancer.
This study will enroll 60 women, older than 60 years of age, with breast cancer not more than 2 cm in size and without evident additional tumoral foci around the tumor or in other areas of the breast. An MSK radiologist will review your mammography to be sure you qualify for this study. You may be asked to undergo additional mammography or other examinations, such as breast ultrasound in order to verify that the tumor is located in a single quadrant of the breast. Some of these procedures are routinely performed in all candidates for conservative breast surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: Intra Operative Radiation Therapy (IORT) |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Core biopsy or prior open biopsy to establish the diagnosis.
- Over age 60.
- No physical or imaging evidence of multicentricity or multifocality.
- Size equal or less than 2.0 cm radiographically, clinically node negative.
- Patients scheduled for breast conserving surgery
Key exclusion criteria (9 listed)
- Patients younger than 61 years
- Patients with evidence of multicentric or multifocal disease seen on imaging (mammography )
- Patients with a lesion exceeding 2 cm radiographically
- Paget's disease or pure DCIS without invasive ductal carcinoma
- Histotype not inclusive of ductal carcinoma
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 Therapy (IORT)Quadrant High Dose Rate Intra Operative Radiation Therapy (IORT) | Radiation | 1 |
Primary outcome
To determine tissue tolerance of the breast to a single intraoperative course of radiation.
Time frame: 7 years
To establish feasibility of the technique in the operating room.
Time frame: 7 years
1 secondary outcome
overall survival
Time frame: 7 years
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 22 Dec 2015.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Beryl McCormick, MD principal investigator
Memorial Sloan Kettering Cancer 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 Intra Operative Radiation Therapy (IORT) in people with Breast Cancer, run by Memorial Sloan Kettering 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 5 inclusion and 9 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 22 Dec 2015. 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 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?
To determine tissue tolerance of the breast to a single intraoperative course of radiation. (time frame: 7 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 22 Dec 2015.