Breast CancerPhase 2IMRT-SIBNCT01394575
Whole Breast Irradiation With Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients
A Phase 2 study testing IMRT with an simultaneous integrated boost in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a phase II study. In patients with node-negative invasive breast cancer or carcinoma in situ treated by breast conserving surgery, postoperative whole breast irradiation with inversely intensity modulated radiotherapy and a simultaneous integrated boost is technically feasible. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IMRT with an simultaneous integrated boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Jul 2013
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group performance score﹤2
- All patients aged >18 years and < 70 years after breast conserving surgery.
- On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
- Negative nodal status determined by sentinel node biopsy, or axillary dissection. Axillary staging is not required for patients with DCIS
- No evidence of distant metastasis
- Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS) tumor size excised with negative margins（>2mm）
- Surgical treatment of the breast must have been lumpectomy. Re-excision of surgical margins is permitted.
- The patient must consent to be in the study and must have signed an approved consent form.
Who cannot join
- Eastern Cooperative Oncology Group performance score≧2
- Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25% of the primary invasive tumour and present adjacent to the primary tumour).Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant of separated.
- Metastatic disease (M1)
- Pregnancy or lactating
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
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- Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Prior breast or thoracic RT for any condition.
- Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.
- Synchronous chemotherapy or target therapy is not permitted.
- Refusal of the patients to be included in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Department of Radiation Oncology,Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Zhaozhi Yang, MD, 862164175590 ext. 6601, yzzhi2006@yahoo.com.cn
Jiayi Chen, MD
About this study
Official title: Phase 2 Study of Whole Breast Irradiation With Inversely Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients
This is a phase II study. In patients with node-negative invasive breast cancer or carcinoma in situ treated by breast conserving surgery, postoperative whole breast irradiation with inversely intensity modulated radiotherapy and a simultaneous integrated boost is technically feasible. The aim of this study is to evaluate the radiation toxicity, cosmetic outcome and local control rate in a single center
- Conditions
- Breast Cancer
- Being tested
- IMRT with an simultaneous integrated boost
- Keywords
- breast cancer, radiotherapy, simultaneous integrated boost, tumor bed, IMRT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT with an simultaneous integrated boostRadiation
IMRT in 25 fractions delivering 45Gy to the whole breast and 60Gy to the tumor bed
| Study group | Role | What they receive |
|---|---|---|
| IMRT-SIB | Experimental | Not described Receives: Radiation: IMRT with an simultaneous integrated boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation toxicity
Measured: first analysis will occur 2 year after accrual of all patients
Cosmetic outcome
Measured: first analysis will occur 2 year after accrual of all patients
Secondary outcomes (4)
Time to ipsilateral breast recurrence
Measured: first analysis will occur 5 year after accrual of all patients
Local recurrence rate
Measured: first analysis will occur 5 year after accrual of all patients
Disease free survival
Measured: first analysis will occur 5 year after accrual of all patients
Overall survival
Measured: first analysis will occur 5 year after accrual of all patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (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 Fudan UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Jiayi Chen, MD, Principal investigator, The Department of Radiation Oncology, Fudan University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394575
- Sponsor's protocol ID
- BR-RT-001
- Acronym
- IMRT-SIB
- Status last verified
- Jun 2011
- First submitted
- 13 Jul 2011
- Last updated
- 27 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Whole Breast Irradiation With Inversely Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01394575
- Acronym / sponsor ID
- IMRT-SIB / BR-RT-001
- Conditions
- Breast Cancer
- Keywords
- breast cancer, radiotherapy, simultaneous integrated boost, tumor bed, IMRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 14 Jul 2011 (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 is a phase II study. In patients with node-negative invasive breast cancer or carcinoma in situ treated by breast conserving surgery, postoperative whole breast irradiation with inversely intensity modulated radiotherapy and a simultaneous integrated boost is technically feasible. The aim of this study is to evaluate the radiation toxicity, cosmetic outcome and local control rate in a single center
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT-SIB | Experimental | Radiation: IMRT with an simultaneous integrated boost |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eastern Cooperative Oncology Group performance score﹤2
- All patients aged >18 years and < 70 years after breast conserving surgery.
- On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
- Negative nodal status determined by sentinel node biopsy, or axillary dissection. Axillary staging is not required for patients with DCIS
- No evidence of distant metastasis
Key exclusion criteria (12 listed)
- Eastern Cooperative Oncology Group performance score≧2
- Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25% of the primary invasive tumour and present adjacent to the primary tumour).Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant of separated.
- Metastatic disease (M1)
- Pregnancy or lactating
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 |
|---|---|---|
| IMRT with an simultaneous integrated boostIMRT in 25 fractions delivering 45Gy to the whole breast and 60Gy to the tumor bed | Radiation | IMRT-SIB |
Primary outcome
Radiation toxicity
Time frame: first analysis will occur 2 year after accrual of all patients
Cosmetic outcome
Time frame: first analysis will occur 2 year after accrual of all patients
4 secondary outcomes
Time to ipsilateral breast recurrence
Time frame: first analysis will occur 5 year after accrual of all patients
Local recurrence rate
Time frame: first analysis will occur 5 year after accrual of all patients
Disease free survival
Time frame: first analysis will occur 5 year after accrual of all patients
Overall survival
Time frame: first analysis will occur 5 year after accrual of all patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2013.
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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.
Jiayi Chen, MD principal investigator
The Department of Radiation Oncology, Fudan University Cancer Hospital
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 IMRT with an simultaneous integrated boost in people with Breast Cancer, run by Fudan University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 27 Mar 2013. 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 China. 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 Zhaozhi Yang, MD (862164175590 ext. 6601, yzzhi2006@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation toxicity (time frame: first analysis will occur 2 year after accrual of all patients). 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 27 Mar 2013.