Breast CancerPhase 2/3NCT05804916
Optical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast Cancer
A Phase 2/3 study testing Surface Guided Radiation Therapy (SGRT) in people with Breast Cancer and Optical Surface Monitoring Technology, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a single-center,blinded, efficacious, phase III randomized clinical trial initiated by investigators. The primary objective is to investigate the use of Surface Guided Radiation Therapy (SGRT) in combination with Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment, compared to… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Optical Surface Monitoring Technology, Large-segment Radiotherapy
- What is being tested?
- Surface Guided Radiation Therapy (SGRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Apr 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer;
- Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy;
- Able to perform deep inspiration breath-hold technique with breath-holding time >35s and can repeat it continuously for more than 6 times;
- Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery;
- No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline;
- Patients are fully voluntary and able to sign the informed consent form 30 days before enrollment.
Who cannot join
- Bilateral breast cancer;
- No pathological diagnosis;
- Remote metastasis;
- Receiving neoadjuvant chemotherapy or breast reconstruction;
- Have received mediastinal radiotherapy in the past;
- Previous history of abdominal or pelvic radiotherapy;
- Previous or secondary primary malignant tumor;
- Serious cardiac insufficiency; Myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina pectoris occurred in the last 3 months; Pericardial disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiaorong HOU, PhD, +86-13811963013, hxr_pumch@163.com
About this study
Official title: A Single-center, Blinded, Efficacious, Phase III Randomized Clinical Trial Initiated by Investigators to Investigate the Use of Surface Guided Radiation Therapy (SGRT) in Combination With Deep Inspiration Breath Hold (DIBH) Technique for Left Breast Cancer Treatment, Compared to Traditional Laser Alignment With Free Breathing Treatment
This study is a single-center,blinded, efficacious, phase III randomized clinical trial initiated by investigators. The primary objective is to investigate the use of Surface Guided Radiation Therapy (SGRT) in combination with Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment, compared to traditional laser alignment with free breathing treatment. This approach offers superior positioning accuracy and improved heart protection without any increase in radiation or adverse reactions.
Read the detailed description
This is an investigator-initiated blinded, efficacious, phase III randomized clinical trial study. The study hypothesis is that the use of Surface Guided Radiation Therapy (SGRT) in combination with the Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment can improve positioning accuracy and heart protection without any increase in radiation or adverse reactions. The primary endpoint of this study is the accuracy of the treatment location and incidence of patient coronary events/myocardial perfusion decline.
- Being tested
- Surface Guided Radiation Therapy (SGRT)
- Keywords
- breast cancer, optical surface monitoring technology, large-segment radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface Guided Radiation Therapy (SGRT)Device
Also called Deep Inspiration Breath Hold (DIBH) technique
SGRT and DIBH those two devices could be combined together to improve the accuracy in radiation therapy position and heart protection
| Study group | Role | What they receive |
|---|---|---|
| SGRT+DIBH group | Experimental | Patients with left breast cancer treated with SGRT combined with DIBH technique Receives: Device: Surface Guided Radiation Therapy (SGRT) |
| common+Free breath group | No intervention | Patients with left breast cancer treated with traditional laser alignment with free breathing treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of treatment location
surface optical monitoring technology and simulation of surface contour registration error generated by surface optical surface error, as well as errors obtained by Cone beam CT registration. The translational errors in the left-right (x), up-down (y), front-back (z) directions, and rotational errors Rx, Ry, Rz will be measured
Measured: Change from baseline to the whole treatment procedure
Incidence of patient coronary events/myocardial perfusion decline
including the cardiac enzymes, ECG and myocardial perfusion
Measured: 3-year
Secondary outcomes (3)
Secondary efficacy indicators
Correlation between surface optical monitoring technology and CBCT offset values Correlation between positioning errors and dose pass rates Patient position movement within fractions
Measured: 3-year
cardiac safety
cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc
Measured: 5-year
patients' quality of life
scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome.
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Apr 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (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 Peking Union Medical College HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group: Patients with left breast cancer treated with traditional laser alignment with a free breathing treatment Study group: Patients with left breast cancer treated with SGRT combined with the DIBH technique
- Masking
- None (open label)
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804916
- Sponsor's protocol ID
- SGRT-BC
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Blinded, Efficacious, Phase III Randomized Clinical Trial Initiated by Investigators to Investigate the Use of Surface Guided Radiation Therapy (SGRT) in Combination With Deep Inspiration Breath Hold (DIBH) Technique for Left Breast Cancer Treatment, Compared to Traditional Laser Alignment With Free Breathing Treatment
- ClinicalTrials.gov ID
- NCT05804916
- Acronym / sponsor ID
- SGRT-BC
- Keywords
- breast cancer, optical surface monitoring technology, large-segment radiotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 7 Apr 2023 (actual)
- 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 study is a single-center,blinded, efficacious, phase III randomized clinical trial initiated by investigators. The primary objective is to investigate the use of Surface Guided Radiation Therapy (SGRT) in combination with Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment, compared to traditional laser alignment with free breathing treatment. This approach offers superior positioning accuracy and improved heart protection without any increase in radiation or adverse reactions.
Detailed description
This is an investigator-initiated blinded, efficacious, phase III randomized clinical trial study. The study hypothesis is that the use of Surface Guided Radiation Therapy (SGRT) in combination with the Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment can improve positioning accuracy and heart protection without any increase in radiation or adverse reactions. The primary endpoint of this study is the accuracy of the treatment location and incidence of patient coronary events/myocardial perfusion decline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group: Patients with left breast cancer treated with traditional laser alignment with a free breathing treatment Study group: Patients with left breast cancer treated with SGRT combined with the DIBH technique
| Arm | Type | Receives |
|---|---|---|
| SGRT+DIBH group | Experimental | Device: Surface Guided Radiation Therapy (SGRT)Patients with left breast cancer treated with SGRT combined with DIBH technique |
| common+Free breath group | No intervention | –Patients with left breast cancer treated with traditional laser alignment with free breathing treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer;
- Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy;
- Able to perform deep inspiration breath-hold technique with breath-holding time >35s and can repeat it continuously for more than 6 times;
- Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery;
- No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline;
Key exclusion criteria (8 listed)
- Bilateral breast cancer;
- No pathological diagnosis;
- Remote metastasis;
- Receiving neoadjuvant chemotherapy or breast reconstruction;
- Have received mediastinal radiotherapy in the past;
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 |
|---|---|---|
| Surface Guided Radiation Therapy (SGRT)Also: Deep Inspiration Breath Hold (DIBH) techniqueSGRT and DIBH those two devices could be combined together to improve the accuracy in radiation therapy position and heart protection | Device | SGRT+DIBH group |
Primary outcome
Accuracy of treatment location
Time frame: Change from baseline to the whole treatment procedure
surface optical monitoring technology and simulation of surface contour registration error generated by surface optical surface error, as well as errors obtained by Cone beam CT registration. The translational errors in the left-right (x), up-down (y), front-back (z) directions, and rotational errors Rx, Ry, Rz will be measured
Incidence of patient coronary events/myocardial perfusion decline
Time frame: 3-year
including the cardiac enzymes, ECG and myocardial perfusion
3 secondary outcomes
Secondary efficacy indicators
Time frame: 3-year
cardiac safety
Time frame: 5-year
patients' quality of life
Time frame: 5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Surface Guided Radiation Therapy (SGRT) in people with Breast Cancer and Optical Surface Monitoring Technology, run by Peking Union Medical College Hospital 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: looking for participants now, as of the sponsor's last update on 7 Apr 2023. 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaorong HOU, PhD (+86-13811963013, hxr_pumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of treatment location (time frame: Change from baseline to the whole treatment procedure). 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 7 Apr 2023.