Breast CancerPhase 1/2NCT02883985
Safety Study of the Hypo-fractionated (Large Doses) Radiation Therapy in Post-menopausal Women With Breast Cancers
A Phase 1/2 study testing 6 Gy/ fraction in people with Breast Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine whether high dose of radiation therapy (RT) are effective over standard 6-week radiation treatment in patients with breast cancer 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?
- 6 Gy/ fraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to Sep 2017
- Phase
- Phase 1/2
- 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
Who may be able to join
- Post-menopausal women (at least 2 years without menstrual period):
- hysterectomized patients need follicle-stimulating hormone (FSH) confirmation of post-menopausal status.
- Original tumor non-palpable (mammographically detected).
- Small primary tumor (pT1) breast cancer, excised with negative margins (defined as at least a 5 mm margin).
- N0 or sentinel node negative or N0 clinically if the tumor is <1 cm in size.
- Patient offered six weeks of post-segmental mastectomy conventional radiation therapy and declined.
- Prescribed antihormonal therapy as part of their management.
Who cannot join
- Previous radiation therapy to the ipsilateral breast.
- Presence of a proportion of ductal carcinoma in situ (DCIS) in the pathology specimen which is compatible with extensive intraductal component (EIC).
- Women incapable of providing their own consent. Mental status will be assessed by the Principal Investigator using the Radiation Therapy Oncology Group (RTOG) Mini-Mental Status Examination.
- Women with a diagnosis of multifocal breast cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Perlmutter Cancer Center
New York, New York, 10016
About this study
Official title: Hypo-Fractionated Conformal Radiation Therapy to the Tumor Bed After Segmental Mastectomy
The purpose of this study is to determine whether high dose of radiation therapy (RT) are effective over standard 6-week radiation treatment in patients with breast cancer
Read the detailed description
Hypo-fractionation (several large fractions as the only radiation treatment) for breast cancer irradiation was common in the forties and 50s and, while very successful in achieving tumor control, was found to leave significantly inferior cosmetic results due to severe fibrosis and telangiectasia compared to those obtained with multiple fraction regimens (38-40). These complications were due to the use of very large fields, with the inclusion of a large proportion of uninvolved skin and tissue surrounding the tumor.
Based on these assumptions, a few large fractions can be safely delivered to breast cancers provided that 1) the target volume is sufficiently small and 2) the radiation technique assures maximum sparing of the surrounding normal tissue. Conformal RT to the tumor bed of T1 breast cancers satisfies both requirements.
- Conditions
- Breast Cancer
- Being tested
- 6 Gy/ fraction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 Gy/ fractionRadiation
All patients will be treated with 6 Gy (measure of radiation dose) /fraction (each radiation session) delivered in 5 fractions over a 2 week period for a total dose of 30 Gy.
In addition to routine care, patients may receive antihormonal drugs as part of your base line treatment.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy: 6 Gy/ fraction | Experimental | All patients will be treated with 6 Gy /fraction delivered in 5 fractions over a 2 week period for a total dose of 30 Gy. Receives: Radiation: 6 Gy/ fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Up to 5 years
Secondary outcomes (2)
TGF-beta 1 determinations
Blood specimens will be collected by venipuncture, before starting treatment, immediately after the last treatment fraction
Measured: From baseline to up to 4 weeks
Ultrasound for target localization
Ultrasound is ideal for imaging soft tissues unobstructed by bone and has been used successfully in conjunction with the treatment of prostate cancer to verify compliance between the daily location of the prostate and the planned location with respect to the treatment linear accelerator. By using ultrasound to image the post-operative tumor bed of the breast in "real-time", the operator may automatically align the tumor bed with treatment machine on each day of treatment
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startMay 2000
- Primary completionSep 2007
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Perez, M.D., Principal investigator, NYU Perlmutter Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883985
- Sponsor's protocol ID
- 9096
- Status last verified
- Dec 2018
- First submitted
- 9 Aug 2016
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Formenti SC, Hsu H, Fenton-Kerimian M, Roses D, Guth A, Jozsef G, Goldberg JD, Dewyngaert JK. Prone accelerated partial breast irradiation after breast-conserving surgery: five-year results of 100 patients. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):606-11. doi: 10.1016/j.ijrobp.2012.01.039. Epub 2012 Apr 9.
PubMed 22494589
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypo-Fractionated Conformal Radiation Therapy to the Tumor Bed After Segmental Mastectomy
- ClinicalTrials.gov ID
- NCT02883985
- Acronym / sponsor ID
- 9096
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2000 (actual)
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Aug 2016 (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 determine whether high dose of radiation therapy (RT) are effective over standard 6-week radiation treatment in patients with breast cancer
Detailed description
Hypo-fractionation (several large fractions as the only radiation treatment) for breast cancer irradiation was common in the forties and 50s and, while very successful in achieving tumor control, was found to leave significantly inferior cosmetic results due to severe fibrosis and telangiectasia compared to those obtained with multiple fraction regimens (38-40). These complications were due to the use of very large fields, with the inclusion of a large proportion of uninvolved skin and tissue surrounding the tumor.
Based on these assumptions, a few large fractions can be safely delivered to breast cancers provided that 1) the target volume is sufficiently small and 2) the radiation technique assures maximum sparing of the surrounding normal tissue. Conformal RT to the tumor bed of T1 breast cancers satisfies both requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy: 6 Gy/ fraction | Experimental | Radiation: 6 Gy/ fractionAll patients will be treated with 6 Gy /fraction delivered in 5 fractions over a 2 week period for a total dose of 30 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Post-menopausal women (at least 2 years without menstrual period):
- hysterectomized patients need follicle-stimulating hormone (FSH) confirmation of post-menopausal status.
- Original tumor non-palpable (mammographically detected).
- Small primary tumor (pT1) breast cancer, excised with negative margins (defined as at least a 5 mm margin).
- N0 or sentinel node negative or N0 clinically if the tumor is <1 cm in size.
Key exclusion criteria (4 listed)
- Previous radiation therapy to the ipsilateral breast.
- Presence of a proportion of ductal carcinoma in situ (DCIS) in the pathology specimen which is compatible with extensive intraductal component (EIC).
- Women incapable of providing their own consent. Mental status will be assessed by the Principal Investigator using the Radiation Therapy Oncology Group (RTOG) Mini-Mental Status Examination.
- Women with a diagnosis of multifocal 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 |
|---|---|---|
| 6 Gy/ fractionAll patients will be treated with 6 Gy (measure of radiation dose) /fraction (each radiation session) delivered in 5 fractions over a 2 week period for a total dose of 30 Gy. In addition to routine care, patients may receive antihormonal drugs as part of your base line treatment. | Radiation | Radiation Therapy: 6 Gy/ fraction |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 5 years
2 secondary outcomes
TGF-beta 1 determinations
Time frame: From baseline to up to 4 weeks
Ultrasound for target localization
Time frame: up to 4 weeks
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 21 Dec 2018.
- Results publication: PubMed 22494589Formenti SC, Hsu H, Fenton-Kerimian M, Roses D, Guth A, Jozsef G, Goldberg JD, Dewyngaert JK. Prone accelerated partial breast irradiation after breast-conserving surgery: five-year results of 100 patients. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):606-11. doi: 10.1016/j.ijrobp.2012.01.039. Epub 2012 Apr 9.
- Prone accelerated partial breast irradiation after breast-conserving surgery: five-year results of 100 patientsLink 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.
Carmen Perez, M.D. principal investigator
NYU Perlmutter Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 6 Gy/ fraction in people with Breast Cancer, run by NYU Langone Health 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 7 inclusion and 4 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 21 Dec 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883985, which also lists 1 linked publication.
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 2018.