Lung CancerNCT06692972
The Regression Pattern of Primary Lesions in Lung Cancer After Definitive Radiotherapy
An observational study of Lung Cancer, run by China-Japan Friendship Hospital at 2 sites in China.
Trial summary
Definitive radiotherapy is one of the important methods for inoperable locally advanced lung cancer. The recommended dose for definitive radiotherapy is 60-70Gy, and the optimal dose is still uncertain. Residual lesion after radiotherapy is a risk factor for recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 500 participants
- Where
- 2 sitesChina
- Study dates
- 25 Dec 2024to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage II-III lung cancer patients who have received definitive radiotherapy.
Who may be able to join
- Age ≥18 years old;
- Stage II-III lung cancer with a clear pathological diagnosis report or medical record, not undergoing surgery before radiotherapy;
- The primary lung lesion received definitive radiotherapy (defined as conventional fractionation radiotherapy with dose ≥50Gy, stereotactic radiotherapy with biologically effective dose ≥100Gy);
- The target lesion of the lung receiving radiotherapy can be measured;
- Imaging data can be obtained before and after radiotherapy;
- Complete radiotherapy as planned, or the actual received dose has reached the defined definitive dose.
Who cannot join
- Before radiotherapy, the primary lesion of the lung had received local treatment such as surgery or ablative treatment;
- The radiotherapy plan was not completed, and the actual dose received did not reach the definitive dose (defined as conventional fractionation radiotherapy with dose <50Gy, stereotactic radiotherapy with biologically effective dose <100Gy)；
- Required imaging data cannot be obtained;
- Other conditions considered by the investigator to be inappropriate for enrollment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Guangying Zhu, 86+010-84205380, zryyfa@163.com
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Zhenming Fu, 86+027-88041911, davidfuzming@whu.edu.cn
About this study
Official title: Exploration of and Model Establishment of the Regression Pattern of Primary Lesions in Lung Cancer After Definitive Radiotherapy
Definitive radiotherapy is one of the important methods for inoperable locally advanced lung cancer. The recommended dose for definitive radiotherapy is 60-70Gy, and the optimal dose is still uncertain. Residual lesion after radiotherapy is a risk factor for recurrence. High doses to targeted tumor areas can effectively improve the local control rate, while minimizing toxic side effects. The regression pattern of primary lesions in lung caner after radiotherapy has not been clarified. This study intends to retrospectively collect clinical data of lung cancer patients with definitive radiotherapy, and explore the pattern of tumor regression after radiotherapy. It will help optimize the radiotherapy plan for lung cancer, so as to improve the efficacy and prognosis.
Read the detailed description
This study intends to retrospectively screen and include participants according to inclusion and exclusion criteria, and collect the clinical data of participants by previous medical records. Imaging tools will be used to quantify changes in the spatial location, diameter and volume of target lesions to evaluate tumor regression rate and radiotherapy efficacy, and to explore tumor regression pattern and establish model. In addition, the relationship between tumor regression rate, incidence of adverse radiation events, prognosis and related factors will be analysed.
- Conditions
- Lung Cancer
- Keywords
- lung cancer, radiotherapy
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor regression rate
(1- post-treatment tumor volume/baseline tumor volume)×100%
Measured: Within 1 year after completion of radiotherapy.
Secondary outcomes (5)
Objective response rate
It refers to the proportion of patients who experience a complete or partial remission of tumors in response to treatment, as determined by RECIST criterion.
Measured: Within 1 year after completion of radiotherapy.
Disease control rate
It refers to the proportion of patients who experience an objective response (complete or partial remission) or stable disease in response to treatment, as determined by RECIST criterion.
Measured: Within 1 year after completion of radiotherapy.
Progression-free survival
It's calculated from the start of treatment until the time of disease progression or the patient's death, whichever comes first.
Measured: From the start of treatment until the time of disease progression or death, assessed up to 120 months.
Overall survival
It measures the length of time from the start of treatment until the death of the patient from any cause.
Measured: From the start of treatment until the time of death, assessed up to 120 months.
Adverse event rate
It refers to the frequency of treatment related adverse event.
Measured: Within 1 year after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start25 Dec 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangying Zhu, China-Japan Friendship Hospital
- Investigators
- Guangying Zhu, M.D., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692972
- Sponsor's protocol ID
- 2024-ZF-38
- Status last verified
- Feb 2025
- First submitted
- 13 Nov 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data including study protocol and statistical analysis plan will be shared after the study is completed and the research results are published.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of and Model Establishment of the Regression Pattern of Primary Lesions in Lung Cancer After Definitive Radiotherapy
- ClinicalTrials.gov ID
- NCT06692972
- Acronym / sponsor ID
- 2024-ZF-38
- Conditions
- Lung Cancer
- Keywords
- lung cancer, radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Nov 2024 (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.
Definitive radiotherapy is one of the important methods for inoperable locally advanced lung cancer. The recommended dose for definitive radiotherapy is 60-70Gy, and the optimal dose is still uncertain. Residual lesion after radiotherapy is a risk factor for recurrence. High doses to targeted tumor areas can effectively improve the local control rate, while minimizing toxic side effects. The regression pattern of primary lesions in lung caner after radiotherapy has not been clarified. This study intends to retrospectively collect clinical data of lung cancer patients with definitive radiotherapy, and explore the pattern of tumor regression after radiotherapy. It will help optimize the radiotherapy plan for lung cancer, so as to improve the efficacy and prognosis.
Detailed description
This study intends to retrospectively screen and include participants according to inclusion and exclusion criteria, and collect the clinical data of participants by previous medical records. Imaging tools will be used to quantify changes in the spatial location, diameter and volume of target lesions to evaluate tumor regression rate and radiotherapy efficacy, and to explore tumor regression pattern and establish model. In addition, the relationship between tumor regression rate, incidence of adverse radiation events, prognosis and related factors will be analysed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage II-III lung cancer patients who have received definitive radiotherapy.
Key inclusion criteria (6 listed)
- Age ≥18 years old;
- Stage II-III lung cancer with a clear pathological diagnosis report or medical record, not undergoing surgery before radiotherapy;
- The primary lung lesion received definitive radiotherapy (defined as conventional fractionation radiotherapy with dose ≥50Gy, stereotactic radiotherapy with biologically effective dose ≥100Gy);
- The target lesion of the lung receiving radiotherapy can be measured;
- Imaging data can be obtained before and after radiotherapy;
Key exclusion criteria (4 listed)
- Before radiotherapy, the primary lesion of the lung had received local treatment such as surgery or ablative treatment;
- The radiotherapy plan was not completed, and the actual dose received did not reach the definitive dose (defined as conventional fractionation radiotherapy with dose <50Gy, stereotactic radiotherapy with biologically effective dose <100Gy)；
- Required imaging data cannot be obtained;
- Other conditions considered by the investigator to be inappropriate for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor regression rate
Time frame: Within 1 year after completion of radiotherapy.
(1- post-treatment tumor volume/baseline tumor volume)×100%
5 secondary outcomes
Objective response rate
Time frame: Within 1 year after completion of radiotherapy.
Disease control rate
Time frame: Within 1 year after completion of radiotherapy.
Progression-free survival
Time frame: From the start of treatment until the time of disease progression or death, assessed up to 120 months.
Overall survival
Time frame: From the start of treatment until the time of death, assessed up to 120 months.
Adverse event rate
Time frame: Within 1 year after completion of radiotherapy.
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 Feb 2025.
- Individual participant dataSharing planned: Yes. Research data including study protocol and statistical analysis plan will be shared after the study is completed and the research results are published.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Guangying Zhu, M.D. principal investigator
China-Japan Friendship Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by China-Japan Friendship Hospital at 2 sites 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 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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Guangying Zhu, M.D. (+86 010-84205380, zryyfa@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor regression rate (time frame: Within 1 year after completion 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 27 Feb 2025.