Stereotactic Body Radiation TherapyNCT05189054
Safety and Efficacy of SBRT in the Reirradiation for Ultra-central Thoracic Malignant Tumors
An observational study of Stereotactic Body Radiation Therapy and Irradiation; Reaction, run by Peking University Third Hospital at 1 site in China.
Trial summary
The reirradiation of thoracic tumor is difficult. The possibility of surgery or re course radiotherapy is very small. In the NCCN guideline, only systemic treatment is recommended. However, the effective rate of systemic treatment is low. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stereotactic Body Radiation Therapy, Irradiation; Reaction, Thoracic Tumor
- What is being tested?
- stereotacitic body radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 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
- Adult, Older adult
Study population: Patients with recurrent chest "ultral-central" malignant tumors after radiotherapy who received SBRT treatment in our department from 2022 to 2023 were expected to be enrolled.
Who may be able to join
- Pathological diagnosis is malignant tumor.
- The location of the target lesion belongs to the ultra-central type of chest.
- The target lesion had a history of radiotherapy, 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
The reirradiation of thoracic tumor is difficult. The possibility of surgery or re course radiotherapy is very small. In the NCCN guideline, only systemic treatment is recommended. However, the effective rate of systemic treatment is low. SBRT has the characteristics of high dose in tumor target area and low dose in surrounding normal tissues. In theory, SBRT is more conducive to the protection of normal tissues and can potentially be used in the salvage treatment of recurrent lesions after radiotherapy. Even so, SBRT is still controversial in the rescue treatment of recurrent lung cancer after radiotherapy, especially for "ultral-central" lesions close to mediastinal structures (such as bronchus, esophagus and large blood vessels), which have a high probability of fatal side effects. However, a few studies on the application of SBRT in the reirradiation for ultral-central lung cancer have shown acceptable safety and efficacy. Generally speaking, there are few studies on SBRT in the treatment of recurrent ultral-central tumor with limited data. The purpose of this study is to further evaluate the efficacy and toxicities of SBRT in the treatment of recurrent ultral-central tumors after radiotherapy.
- Conditions
- Stereotactic Body Radiation Therapy, Irradiation; Reaction, Thoracic Tumor, Recurrent Cancer
- Being tested
- stereotacitic body radiation therapy
- Medical subject headings
- Thoracic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotacitic body radiation therapyRadiation
The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxcicties
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 3 years after the treatment.
Local control time
The time from the date of SBRT to the date of recurrence of the target tumor or the date of last observation.
Measured: From the beginning of the treatment to 3 years after the treatment.
Secondary outcomes (2)
Overall survival time
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 3 years after the treatment.
Disease progression time
The time from the date of SBRT to the date of disease progression from any cause or the date of last observation.
Measured: From the beginning of the treatment to 3 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 posted12 Jan 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 Stereotactic Body Radiation TherapyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junjie Wang, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189054
- Sponsor's protocol ID
- BYSY-2021-SBRT-UC
- Status last verified
- Oct 2023
- First submitted
- 26 Dec 2021
- 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 Reirradiation for Ultra-central Thoracic Malignant Tumors
- ClinicalTrials.gov ID
- NCT05189054
- Acronym / sponsor ID
- BYSY-2021-SBRT-UC
- Conditions
- Stereotactic Body Radiation Therapy, Irradiation; Reaction, Thoracic Tumor, Recurrent Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 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
- 12 Jan 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.
The reirradiation of thoracic tumor is difficult. The possibility of surgery or re course radiotherapy is very small. In the NCCN guideline, only systemic treatment is recommended. However, the effective rate of systemic treatment is low. SBRT has the characteristics of high dose in tumor target area and low dose in surrounding normal tissues. In theory, SBRT is more conducive to the protection of normal tissues and can potentially be used in the salvage treatment of recurrent lesions after radiotherapy. Even so, SBRT is still controversial in the rescue treatment of recurrent lung cancer after radiotherapy, especially for "ultral-central" lesions close to mediastinal structures (such as bronchus, esophagus and large blood vessels), which have a high probability of fatal side effects. However, a few studies on the application of SBRT in the reirradiation for ultral-central lung cancer have shown acceptable safety and efficacy. Generally speaking, there are few studies on SBRT in the treatment of recurrent ultral-central tumor with limited data. The purpose of this study is to further evaluate the efficacy and toxicities of SBRT in the treatment of recurrent ultral-central tumors after radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent chest "ultral-central" malignant tumors after radiotherapy who received SBRT treatment in our department from 2022 to 2023 were expected to be enrolled.
Key inclusion criteria (5 listed)
- Pathological diagnosis is malignant tumor.
- The location of the target lesion belongs to the ultra-central type of chest.
- The target lesion had a history of radiotherapy, 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 |
|---|---|---|
| stereotacitic body radiation therapyThe patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology. | Radiation | – |
Primary outcome
Toxcicties
Time frame: From the beginning of the treatment to 3 years after the treatment.
Adverse events of radiation of normal tissues (Including lung, trachea, bronchus, esophagus, blood vessels, ribs, spinal cord, brachial plexus).
Local control time
Time frame: From the beginning of the treatment to 3 years after the treatment.
The time from the date of SBRT to the date of recurrence of the target tumor or the date of last observation.
2 secondary outcomes
Overall survival time
Time frame: From the beginning of the treatment to 3 years after the treatment.
Disease progression time
Time frame: From the beginning of the treatment to 3 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.
Junjie Wang, M.D. principal investigator
Peking University Third Hospital
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 Stereotactic Body Radiation Therapy and Irradiation; Reaction, 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 5 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?
Toxcicties (time frame: From the beginning of the treatment to 3 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.