Breast CancerPhase 4NCT00882596
Use of the Contura™ Catheter to Deliver Accelerated Partial Breast Irradiation to "Low-risk" Breast Cancer Patients
A Phase 4 study testing Accelerated partial breast irradiation in people with Breast Cancer, run by Cancer Center of Irvine at 1 site in United States.
Trial summary
The purpose of this national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation. 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?
- Accelerated partial breast irradiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2013
- Phase
- Phase 4
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to sign informed consent
- Age 50 or older at diagnosis
- Life expectancy greater than 10 years (excluding diagnosis of breast cancer)
- Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria)
- On histologic examination, the tumor must be DCIS and/or invasive breast carcinoma
- For patients with invasive breast cancer, an axillary staging procedure must be performed [either sentinel node biopsy or axillary dissection (with a minimum of 6 axillary nodes removed), and the axillary node(s) must be pathologically negative]
- The T stage must be Tis, T1, or T2. If T2, the tumor must be less than or equal to 3.0 cm in maximum diameter
- Estrogen receptor positive tumor
Who cannot join
- Age < 50 at diagnosis (regardless of histology)
- Pregnant or breast-feeding
- Active collagen vascular disease
- Paget's disease of the breast
- Prior history of DCIS or invasive breast cancer
- Prior breast or thoracic radiation therapy for any condition
Show all 12Show fewer
- Multicentric carcinoma (DCIS or invasive)
- Synchronous bilateral invasive or non-invasive breast cancer
- Surgical margins that cannot be microscopically assessed or that are positive
- Positive axillary node(s)
- T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage of T3 or T4
- Estrogen receptor negative tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity
The purpose of this national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.
Read the detailed description
The Cancer Center of Irvine is one of the busiest centers in the United States for Contura accelerated partial breast irradiation.
- Conditions
- Breast Cancer
- Being tested
- Accelerated partial breast irradiation
- Keywords
- Contura, Cancer, Accelerated, Partial, Breast, Irradiation
- 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.
Accelerated partial breast irradiationDevice
Also called Contura catheter
A total radiation dose of 34 Gy is delivered in 10 fractions bid over 5-7 days with 6 hours between the radiation treatments each day. Each radiation treatment takes 15-30 minutes. There is no radioactivity left behind in the patient.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Contura accelerated partial breast irradiation. Following a lumpectomy, a Contura balloon catheter is placed in the lumpectomy cavity. Later that morning, accelerated partial breast irradiation begins. Receives: Device: Accelerated partial breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.
Measured: 19 months
Secondary outcomes (1)
Toxicity rates
Measured: 79 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startMay 2008
- Primary completionMay 2013
- 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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Center of Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth M Tokita, MD, Principal investigator, Cancer Center of IrvineRichard B Wilder, MD, Study director, Cancer Center of Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882596
- Sponsor's protocol ID
- S07-002
- Other IDs
- 1098558
- Status last verified
- Jan 2018
- First submitted
- 15 Apr 2009
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity
- ClinicalTrials.gov ID
- NCT00882596
- Acronym / sponsor ID
- S07-002
- Conditions
- Breast Cancer
- Keywords
- Contura, Cancer, Accelerated, Partial, Breast, Irradiation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cancer Center of IrvineUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Apr 2009 (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 national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.
Detailed description
The Cancer Center of Irvine is one of the busiest centers in the United States for Contura accelerated partial breast irradiation.
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 | Device: Accelerated partial breast irradiationContura accelerated partial breast irradiation. Following a lumpectomy, a Contura balloon catheter is placed in the lumpectomy cavity. Later that morning, accelerated partial breast irradiation begins. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able and willing to sign informed consent
- Age 50 or older at diagnosis
- Life expectancy greater than 10 years (excluding diagnosis of breast cancer)
- Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria)
- On histologic examination, the tumor must be DCIS and/or invasive breast carcinoma
Key exclusion criteria (12 listed)
- Age < 50 at diagnosis (regardless of histology)
- Pregnant or breast-feeding
- Active collagen vascular disease
- Paget's disease of the breast
- Prior history of DCIS or invasive breast cancer
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 |
|---|---|---|
| Accelerated partial breast irradiationAlso: Contura catheterA total radiation dose of 34 Gy is delivered in 10 fractions bid over 5-7 days with 6 hours between the radiation treatments each day. Each radiation treatment takes 15-30 minutes. There is no radioactivity left behind in the patient. | Device | 1 |
Primary outcome
Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.
Time frame: 19 months
1 secondary outcome
Toxicity rates
Time frame: 79 months
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 25 Jan 2018.
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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.
Kenneth M Tokita, MD principal investigator
Cancer Center of Irvine
Richard B Wilder, MD study director
Cancer Center of Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Accelerated partial breast irradiation in people with Breast Cancer, run by Cancer Center of Irvine 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 8 inclusion and 12 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 25 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose. (time frame: 19 months). 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 25 Jan 2018.