Breast CancerPhase 2NCT02231112
Whole Breast RT on Prone Position in Korean Women
A Phase 2 study testing Whole breast RT on prone position in people with Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
It is well known fact that postoperative whole breast radiation therapy (RT) in left breast cancer patient can cause cardiac problem according to the exposed dose. In the several studies in other countries, it was repeatedly showed that RT on prone position can reduce cardiac exposed RT dose in left breast cancer. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Whole breast RT on prone position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Sep 2015
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed left breast cancer
- 20 or older age
- less than 70 years old
- after curative resection
- Eastern Cooperative Oncology Group performance status 0 to 1
- Informed consent to this study
- Consent to contraception for 6 months after RT completion
Who cannot join
- Male breast cancer
- Combined distant metastasis
- Status of pregnant or brest feeding
- Previous RT history of chest or neck area
- Indication of supraclavicular RT
- Not indicated postoperative whole breast RT
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Doo Ho Choi, M.D., Ph.D., 82-2-3410-2612, doho.choi@samsung.com
Doo Ho Choi, M.D., Ph.D.
About this study
Official title: Feasibility of Prone Position in Postoperative Whole Breast Radiation Therapy in Korean Breast Cancer Patient
It is well known fact that postoperative whole breast radiation therapy (RT) in left breast cancer patient can cause cardiac problem according to the exposed dose. In the several studies in other countries, it was repeatedly showed that RT on prone position can reduce cardiac exposed RT dose in left breast cancer. However, the effectiveness of prone position in RT is not studied in the Korean women have relatively small breast. The investigators planned this study to evaluate the real efficacy of prone position in Korean breast cancer treated with RT.
- Conditions
- Breast Cancer
- Being tested
- Whole breast RT on prone position
- Keywords
- Korean, Left side
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole breast RT on prone positionRadiation
| Study group | Role | What they receive |
|---|---|---|
| Prone position whole breast RT | Experimental | Not described Receives: Radiation: Whole breast RT on prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irradiated cardiac dose
Measured: At simulation, expected average of 1 week
Secondary outcomes (6)
Irradiated dose of left anterior descending artery
Measured: At simulation, expected average of 1 week
Irradiated lung dose
Measured: At simulation, expected average of 1 week
Clinical target volume (volume, homogeneity index, conformity index)
Measured: At simulation, expected average of 1 week
Irradiated dose of axillary lymphatic area
Measured: At simulation, expected average of 1 week
Skin change after RT
Measured: At 3 months after RT completion
Breast shape after RT
Measured: At 6 months after RT completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
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 Samsung Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doo Ho Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231112
- Sponsor's protocol ID
- 2014-06-138-001
- Status last verified
- Nov 2014
- First submitted
- 25 Aug 2014
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Prone Position in Postoperative Whole Breast Radiation Therapy in Korean Breast Cancer Patient
- ClinicalTrials.gov ID
- NCT02231112
- Acronym / sponsor ID
- 2014-06-138-001
- Conditions
- Breast Cancer
- Keywords
- Korean, Left side
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 4 Sep 2014 (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.
It is well known fact that postoperative whole breast radiation therapy (RT) in left breast cancer patient can cause cardiac problem according to the exposed dose. In the several studies in other countries, it was repeatedly showed that RT on prone position can reduce cardiac exposed RT dose in left breast cancer. However, the effectiveness of prone position in RT is not studied in the Korean women have relatively small breast. The investigators planned this study to evaluate the real efficacy of prone position in Korean breast cancer treated with RT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prone position whole breast RT | Experimental | Radiation: Whole breast RT on prone position |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed left breast cancer
- 20 or older age
- less than 70 years old
- after curative resection
- Eastern Cooperative Oncology Group performance status 0 to 1
Key exclusion criteria (6 listed)
- Male breast cancer
- Combined distant metastasis
- Status of pregnant or brest feeding
- Previous RT history of chest or neck area
- Indication of supraclavicular RT
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 |
|---|---|---|
| Whole breast RT on prone position | Radiation | Prone position whole breast RT |
Primary outcome
Irradiated cardiac dose
Time frame: At simulation, expected average of 1 week
6 secondary outcomes
Irradiated dose of left anterior descending artery
Time frame: At simulation, expected average of 1 week
Irradiated lung dose
Time frame: At simulation, expected average of 1 week
Clinical target volume (volume, homogeneity index, conformity index)
Time frame: At simulation, expected average of 1 week
Irradiated dose of axillary lymphatic area
Time frame: At simulation, expected average of 1 week
Skin change after RT
Time frame: At 3 months after RT completion
Breast shape after RT
Time frame: At 6 months after RT completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 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.
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 Whole breast RT on prone position in people with Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 6 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: status not confirmed, as of the sponsor's last update on 7 Nov 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doo Ho Choi, M.D., Ph.D. (82-2-3410-2612, doho.choi@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irradiated cardiac dose (time frame: At simulation, expected average of 1 week). 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 7 Nov 2014.