RadiotherapyNCT05349552
Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites
An observational study of Radiotherapy and Thoracic Cancer, run by Peking University Third Hospital at 1 site in China.
Trial summary
SBRT (stereotactic radiotherapy) can provide a higher dose to the target area without increasing the risk of surrounding normal tissue / organ injury in selective cases. At present, SBRT has been widely used in radiotherapy of lung cancer and it can also play a better local control for lung metastasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiotherapy, Thoracic Cancer, Safety and Efficacy
- What is being tested?
- stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Apr 2027
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chest malignant tumors who received SBRT treatment in our department from 2022 to 2025 are expected to be enrolled.
Who may be able to join
- Pathological diagnosis was malignant tumor.
- The location of the target lesion belongs to one of five types and the lesion diameter is ≤ 5cm.
- There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by previous treatment.
- KPS>70, no serious or uncontrolled underlying diseases, such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, and patients are expected to be tolerated by radiotherapy.
Who cannot join
- Poor basic pulmonary function or symptom correlation caused by various reasons, unable to lie flat or cooperate with treatment.
- The general condition is poor, and the expected survival time is less than 3 months.
- Psychiatric patients or poor compliance, unable to cooperate to complete treatment.
- For other reasons, the researcher believes that it is not suitable to participate in this trial.
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 University Third Hospital
Beijing, Beijing Municipality, 100191
Junjie Wang, M.D., 00861082265921, junjiewang_edu@sina.cn
Zhe Ji, M.D., 008618710002823, aschoff@163.com
About this study
SBRT (stereotactic radiotherapy) can provide a higher dose to the target area without increasing the risk of surrounding normal tissue / organ injury in selective cases. At present, SBRT has been widely used in radiotherapy of lung cancer and it can also play a better local control for lung metastasis.
However, there are parallel organs and series organs in the chest, and different organs have different tolerance to radiotherapy, so the toxicities of SBRT in different sites are different, and the prescription dose is also different.
Read more
This study intends to make a detailed division of the chest region and explore the safety and efficacy of SBRT in different areas. It is divided into four types: chest wall type: the lesion is directly adjacent or overlapped with the chest wall; peripheral type: the lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree; central type: the lesion is less than 2cm away from the bronchial tree; ultral-central type: the lesion is directly adjacent or overlapped with the mediastinal structure.
48-60Gy / 4-10f (EQD2 = 62.5Gy ~ 99.7Gy) was given according to the location of the tumor. Main outcome measures are local progression free survival and radiation toxicities; secondary outcome measure is overall survival.
- Conditions
- Radiotherapy, Thoracic Cancer, Safety and Efficacy
- Being tested
- stereotactic body radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiation therapyRadiation
The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.
| Study group | Role | What they receive |
|---|---|---|
| Chest Wall Type | The lesion is directly adjacent (less than 1cm) or overlapped with the chest wall. Receives: Radiation: stereotactic body radiation therapy | |
| Peripheral Type | The lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree. Receives: Radiation: stereotactic body radiation therapy | |
| Central Type | The lesion is less than 2cm away from the bronchial tree. Receives: Radiation: stereotactic body radiation therapy | |
| Ultral-central Type | The lesion is directly adjacent or overlapped with the mediastinal structure. Receives: Radiation: stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local progression free survival
The time from the date of SBRT to the date of local recurrence or death or the date of last observation.
Measured: From the beginning of the treatment to 2 years after the treatment.
Toxicities
Adverse events of radiation of normal tissues (Including lung, trachea, bronchus, esophagus, blood vessels, ribs, spinal cord, brachial plexus).
Measured: From the beginning of the treatment to 2 years after the treatment.
Secondary outcomes (1)
Overall survival
The time from the date of SBRT to the date of death from any cause or the date of last observation.
Measured: From the beginning of the treatment to 2 years after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 May 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349552
- Sponsor's protocol ID
- BYSY-2022-SBRT-LC
- Status last verified
- Dec 2023
- First submitted
- 21 Apr 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites
- ClinicalTrials.gov ID
- NCT05349552
- Acronym / sponsor ID
- BYSY-2022-SBRT-LC
- Conditions
- Radiotherapy, Thoracic Cancer, Safety and Efficacy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 Apr 2022 (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.
SBRT (stereotactic radiotherapy) can provide a higher dose to the target area without increasing the risk of surrounding normal tissue / organ injury in selective cases. At present, SBRT has been widely used in radiotherapy of lung cancer and it can also play a better local control for lung metastasis.
However, there are parallel organs and series organs in the chest, and different organs have different tolerance to radiotherapy, so the toxicities of SBRT in different sites are different, and the prescription dose is also different.
This study intends to make a detailed division of the chest region and explore the safety and efficacy of SBRT in different areas. It is divided into four types: chest wall type: the lesion is directly adjacent or overlapped with the chest wall; peripheral type: the lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree; central type: the lesion is less than 2cm away from the bronchial tree; ultral-central type: the lesion is directly adjacent or overlapped with the mediastinal structure.
48-60Gy / 4-10f (EQD2 = 62.5Gy ~ 99.7Gy) was given according to the location of the tumor. Main outcome measures are local progression free survival and radiation toxicities; secondary outcome measure is overall survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chest Wall Type | – | Radiation: stereotactic body radiation therapyThe lesion is directly adjacent (less than 1cm) or overlapped with the chest wall. |
| Peripheral Type | – | Radiation: stereotactic body radiation therapyThe lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree. |
| Central Type | – | Radiation: stereotactic body radiation therapyThe lesion is less than 2cm away from the bronchial tree. |
| Ultral-central Type | – | Radiation: stereotactic body radiation therapyThe lesion is directly adjacent or overlapped with the mediastinal structure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chest malignant tumors who received SBRT treatment in our department from 2022 to 2025 are expected to be enrolled.
Key inclusion criteria (4 listed)
- Pathological diagnosis was malignant tumor.
- The location of the target lesion belongs to one of five types and the lesion diameter is ≤ 5cm.
- There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by previous treatment.
- KPS>70, no serious or uncontrolled underlying diseases, such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, and patients are expected to be tolerated by radiotherapy.
Key exclusion criteria (4 listed)
- Poor basic pulmonary function or symptom correlation caused by various reasons, unable to lie flat or cooperate with treatment.
- The general condition is poor, and the expected survival time is less than 3 months.
- Psychiatric patients or poor compliance, unable to cooperate to complete treatment.
- For other reasons, the researcher believes that it is not suitable to participate in this trial.
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 |
|---|---|---|
| stereotactic body radiation therapyThe patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology. | Radiation | Central Type, Chest Wall Type, Peripheral Type, Ultral-central Type |
Primary outcome
Local progression free survival
Time frame: From the beginning of the treatment to 2 years after the treatment.
The time from the date of SBRT to the date of local recurrence or death or the date of last observation.
Toxicities
Time frame: From the beginning of the treatment to 2 years after the treatment.
Adverse events of radiation of normal tissues (Including lung, trachea, bronchus, esophagus, blood vessels, ribs, spinal cord, brachial plexus).
1 secondary outcome
Overall survival
Time frame: From the beginning of the treatment to 2 years after the treatment.
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 27 Dec 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy and Thoracic Cancer, run by Peking University Third 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 4 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: looking for participants now, as of the sponsor's last update on 27 Dec 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.
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 Zhe Ji, M.D. (008618710002823, aschoff@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local progression free survival (time frame: From the beginning of the treatment to 2 years after the treatment.). 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 Dec 2023.