Breast CancerNCT00165581
High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Breast Carcinoma
A study testing High Dose Intracavitary Brachytherapy in people with Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is to understand the side effects (skin reaction, infection and abscess formation) at the site of radiation treatment, which my occur during the treatment and following 2 months using a new method of radiation therapy for breast cancer. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- High Dose Intracavitary Brachytherapy
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2002to Oct 2006
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AJCC stage I or II histologically confirmed invasive ductal carcinoma of the breast with a lesion < or = to 3cm, treated with partial mastectomy
- 45 years of age or older
- Negative inked pathologic specimen
- > or = to 3mm margins of partial mastectomy or re-excision specimen to be confirmed prior to introducing radiation source
- Negative post-partial mastectomy or post re-excision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before brachytherapy
- Invasive ductal, medullary, papillary, colloid, or tubular histologies
- Time interval from final definitive breast surgical procedure to brachytherapy treatment is less than 8 weeks
Who cannot join
- Distant metastases
- Invasive lobular carcinoma or pure ductal carcinoma in situ or nonepithelial breast malignancies such as sarcoma or lymphoma
- Proven multifocal, multicentric carcinoma with other clinically or radiologically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
- Pregnant or lactating
- Confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
- Prior non-hormonal therapy for the present breast cancer, including radiation therapy and chemotherapy
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- Collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, keloid, ataxia, telangiectasia, or dermatomyositis
- Co-existing medical condition in whom life expectancy is < 2 years
- Psychiatric or addictive disorders
- Paget's disease of the nipple
- Skin involvement regardless of size
- Breast unsatisfactory for brachytherapy
- Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation
- Extensive intraductal carcinoma
- Any previously treated contralateral breast carcinoma or synchronous bilateral breast carcinoma
- Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in this study
- Diffuse suspicious microcalcifications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Clinical Trial to Evaluate High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Favorable Stage I and II Breast Cancer
The purpose of this study is to understand the side effects (skin reaction, infection and abscess formation) at the site of radiation treatment, which my occur during the treatment and following 2 months using a new method of radiation therapy for breast cancer.
Read the detailed description
- Radiation treatment will be delivered in an outpatient setting, twice a day in 5 consecutive treatment days. There will be a minimum 6-hour interval between the two daily treatments. The applicator is a simple tube with an inflatable balloon at one end, a channel in the middle of the tube for treatment, and two adapters at the other end.
- Following surgical removal of the breast cancer, the radiation oncologist with the assistance of the surgeon or radiologist will place the applicator in the surgical cavity. A small radioactive source, iridium-192, will be inserted into the applicator by a special machine and after the final treatment, the applicator will be removed.
- The following procedures will be done while the patient is on radiation therapy: post-partial mastectomy mammogram of micro-calcifications to confirm complete removal; CT scans for radiation treatment planning; monitoring of the skin for side effects; photographs of the breasts prior to the surgery, prior to placement of the applicator and at 60 days after radiation treatment to evaluate the cosmetic outcome of the treatment.
- Participation in this study will last approximately 2 months after completion of radiation treatment.
- Conditions
- Breast Cancer
- Being tested
- High Dose Intracavitary Brachytherapy
- Keywords
- Intracavitary brachytherapy, radiation therapy, Stage I breast cancer, Stage II 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.
High Dose Intracavitary BrachytherapyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the technical feasibility and acute 60-day toxicity of intracavitary HDR brachytherapy when used as the sole method of radiation therapy for patients with Stage I and II breast cancer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionOct 2006
- Study completionOct 2006
Why it stopped: Due to continuing review
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 Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Investigators
- Phillip M. Devlin, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165581
- Sponsor's protocol ID
- 02-259
- Status last verified
- Dec 2007
- First submitted
- 13 Sep 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial to Evaluate High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Favorable Stage I and II Breast Cancer
- ClinicalTrials.gov ID
- NCT00165581
- Acronym / sponsor ID
- 02-259
- Conditions
- Breast Cancer
- Keywords
- Intracavitary brachytherapy, radiation therapy, Stage I breast cancer, Stage II breast cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to continuing review
- Enrolment
- 15 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Dec 2002
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 14 Sep 2005 (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 purpose of this study is to understand the side effects (skin reaction, infection and abscess formation) at the site of radiation treatment, which my occur during the treatment and following 2 months using a new method of radiation therapy for breast cancer.
Detailed description
- Radiation treatment will be delivered in an outpatient setting, twice a day in 5 consecutive treatment days. There will be a minimum 6-hour interval between the two daily treatments. The applicator is a simple tube with an inflatable balloon at one end, a channel in the middle of the tube for treatment, and two adapters at the other end.
- Following surgical removal of the breast cancer, the radiation oncologist with the assistance of the surgeon or radiologist will place the applicator in the surgical cavity. A small radioactive source, iridium-192, will be inserted into the applicator by a special machine and after the final treatment, the applicator will be removed.
- The following procedures will be done while the patient is on radiation therapy: post-partial mastectomy mammogram of micro-calcifications to confirm complete removal; CT scans for radiation treatment planning; monitoring of the skin for side effects; photographs of the breasts prior to the surgery, prior to placement of the applicator and at 60 days after radiation treatment to evaluate the cosmetic outcome of the treatment.
- Participation in this study will last approximately 2 months after completion of radiation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- AJCC stage I or II histologically confirmed invasive ductal carcinoma of the breast with a lesion < or = to 3cm, treated with partial mastectomy
- 45 years of age or older
- Negative inked pathologic specimen
- > or = to 3mm margins of partial mastectomy or re-excision specimen to be confirmed prior to introducing radiation source
- Negative post-partial mastectomy or post re-excision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before brachytherapy
Key exclusion criteria (17 listed)
- Distant metastases
- Invasive lobular carcinoma or pure ductal carcinoma in situ or nonepithelial breast malignancies such as sarcoma or lymphoma
- Proven multifocal, multicentric carcinoma with other clinically or radiologically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
- Pregnant or lactating
- Confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
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 |
|---|---|---|
| High Dose Intracavitary Brachytherapy | Device | – |
Primary outcome
To evaluate the technical feasibility and acute 60-day toxicity of intracavitary HDR brachytherapy when used as the sole method of radiation therapy for patients with Stage I and II breast cancer.
Results and safety
The study was stopped early (reason given: Due to continuing review). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
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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.
Phillip M. Devlin, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Dose Intracavitary Brachytherapy in people with Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites 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 7 inclusion and 17 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 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 stopped early (reason given: Due to continuing review). Results are not available in the source record.
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 the technical feasibility and acute 60-day toxicity of intracavitary HDR brachytherapy when used as the sole method of radiation therapy for patients with Stage I and II breast cancer.. 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 21 Dec 2007.