Clinical trial NCT06692972: The Regression Pattern of Primary Lesions in Lung Cancer After Definitive Radiotherapy
Official title: Exploration of and Model Establishment of the Regression Pattern of Primary Lesions in Lung Cancer After Definitive Radiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: lung cancer
radiotherapy
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage II-III lung cancer patients who have received definitive radiotherapy.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old;
2. Stage II-III lung cancer with a clear pathological diagnosis report or medical record, not undergoing surgery before radiotherapy;
3. The primary lung lesion received definitive radiotherapy (defined as conventional fractionation radiotherapy with dose ≥50Gy, stereotactic radiotherapy with biologically effective dose ≥100Gy);
4. The target lesion of the lung receiving radiotherapy can be measured;
5. Imaging data can be obtained before and after radiotherapy;
6. Complete radiotherapy as planned, or the actual received dose has reached the defined definitive dose.

Exclusion Criteria：

1. Before radiotherapy, the primary lesion of the lung had received local treatment such as surgery or ablative treatment;
2. 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)；
3. Required imaging data cannot be obtained;
4. Other conditions considered by the investigator to be inappropriate for enrollment.

Primary outcomes:
measure: Tumor regression rate
timeFrame: Within 1 year after completion of radiotherapy.
Secondary outcomes:
measure: Objective response rate
timeFrame: Within 1 year after completion of radiotherapy.
measure: Disease control rate
timeFrame: Within 1 year after completion of radiotherapy.
measure: Progression-free survival
timeFrame: From the start of treatment until the time of disease progression or death, assessed up to 120 months.
measure: Overall survival
timeFrame: From the start of treatment until the time of death, assessed up to 120 months.
measure: Adverse event rate
timeFrame: Within 1 year after completion of radiotherapy.
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: China-Japan Friendship Hospital
name: Guangying Zhu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: