Early-stage Breast CancerPhase 3NCT02958033
Shandong Cancer Hospital Affiliated to Shandong University
A Phase 3 study testing Whole Breast irradiation Plus simultaneous tumor bed Boost in people with Early-stage Breast Cancer and Breast Conserving Surgery, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Early-stage Breast Cancer, Breast Conserving Surgery
- What is being tested?
- Whole Breast irradiation Plus simultaneous tumor bed Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Nov 2024
- Phase
- Phase 3
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients has had breast conserving surgery
- age ≥ 18 and ≤ 65 years
- with a histological diagnosis of invasive carcinoma of the breast
- with pathological stage of T1-2N0-1M0
- multidisciplinary decision of adjuvant WBI with a boost to the tumor bed
- informed consent obtained, signed and dated before specific protocol procedures
Who cannot join
- patients treated with Mastectomy
- Need for lymph node irradiation
- positive or close(≤ 1 mm) surgical margin
- treated with neoadjuvant chemotherapy before surgery
- Bilateral malignancy of the breast (synchronous or metachronous)
- Pregnant or breastfeeding
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiyan Road No.440
Jinan, Shandong, 250117
Min Xu, +86-531-67626132, xumin7799@sina.com
About this study
In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.
- Being tested
- Whole Breast irradiation Plus simultaneous tumor bed Boost
- 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 irradiation Plus simultaneous tumor bed BoostRadiation
hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group
| Study group | Role | What they receive |
|---|---|---|
| HF WBI-SIB breast radiation | Experimental | WBI-SIB breast radiation(WBI 2.5Gy x18 and SIB 2.88Gy x18) Receives: Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost |
| CF WBI-SIB breast radiation | Placebo comparator | WBI-SIB breast radiation(WBI 1.8Gy x28 and SIB 2.15Gy x28) Receives: Radiation: Whole Breast irradiation Plus simultaneous tumor bed Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of acute skin toxicity
To determine the acute toxicity of accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost
Measured: 2 Weeks after the end of radiotherapy.
Secondary outcomes (5)
local control
To determine the local control in women with early stage breast cancer treated with accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost
Measured: From data of randomization until 60 months after the end of radiotherapy of last patients
Degree of chronic skin toxicity and cosmesis after radiotherapy
To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost.
Measured: 6 months after radiotherapy
Degree of chronic skin toxicity and cosmesis after radiotherapy
To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost.
Measured: 2 years after radiotherapy
Degree of chronic skin toxicity and cosmesis after radiotherapy
To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost.
Measured: 5 years after radiotherapy
overall survival
To determine whether the overall survival after hypo-fractionated breast radiation with concurrent boost is non-inferior to conventional fractionated radiation therapy with concurrent boost.
Measured: From date of randomization until 60 months after the end of radiotherapy of last patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2019 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Xu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958033
- Sponsor's protocol ID
- Shandong Cancer Hospital
- Status last verified
- Nov 2016
- First submitted
- 18 Oct 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shandong Cancer Hospital Affiliated to Shandong University
- ClinicalTrials.gov ID
- NCT02958033
- Acronym / sponsor ID
- Shandong Cancer Hospital
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 8 Nov 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.
In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF WBI-SIB breast radiation | Experimental | Radiation: Whole Breast irradiation Plus simultaneous tumor bed BoostWBI-SIB breast radiation(WBI 2.5Gy x18 and SIB 2.88Gy x18) |
| CF WBI-SIB breast radiation | Placebo comparator | Radiation: Whole Breast irradiation Plus simultaneous tumor bed BoostWBI-SIB breast radiation(WBI 1.8Gy x28 and SIB 2.15Gy x28) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients has had breast conserving surgery
- age ≥ 18 and ≤ 65 years
- with a histological diagnosis of invasive carcinoma of the breast
- with pathological stage of T1-2N0-1M0
- multidisciplinary decision of adjuvant WBI with a boost to the tumor bed
Key exclusion criteria (8 listed)
- patients treated with Mastectomy
- Need for lymph node irradiation
- positive or close(≤ 1 mm) surgical margin
- treated with neoadjuvant chemotherapy before surgery
- Bilateral malignancy of the breast (synchronous or metachronous)
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 irradiation Plus simultaneous tumor bed Boosthypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group | Radiation | CF WBI-SIB breast radiation, HF WBI-SIB breast radiation |
Primary outcome
Degree of acute skin toxicity
Time frame: 2 Weeks after the end of radiotherapy.
To determine the acute toxicity of accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost
5 secondary outcomes
local control
Time frame: From data of randomization until 60 months after the end of radiotherapy of last patients
Degree of chronic skin toxicity and cosmesis after radiotherapy
Time frame: 6 months after radiotherapy
Degree of chronic skin toxicity and cosmesis after radiotherapy
Time frame: 2 years after radiotherapy
Degree of chronic skin toxicity and cosmesis after radiotherapy
Time frame: 5 years after radiotherapy
overall survival
Time frame: From date of randomization until 60 months after the end of radiotherapy of last patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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 3 study testing Whole Breast irradiation Plus simultaneous tumor bed Boost in people with Early-stage Breast Cancer and Breast Conserving Surgery, run by Shandong Cancer Hospital and Institute 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 6 inclusion and 8 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 8 Nov 2016. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Min Xu (+86-531-67626132, xumin7799@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of acute skin toxicity (time frame: 2 Weeks after the end of radiotherapy.). 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 8 Nov 2016.