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NCT Number: NCT06692972

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China-Japan Friendship Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Tumor regression rate

    Time frame: Within 1 year after completion of radiotherapy.

    (1- post-treatment tumor volume/baseline tumor volume)×100%

Secondary outcomes

  1. Objective response rate

    Time frame: Within 1 year after completion of radiotherapy.

    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.

  2. Disease control rate

    Time frame: Within 1 year after completion of radiotherapy.

    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.

  3. Progression-free survival

    Time frame: From the start of treatment until the time of disease progression or death, assessed up to 120 months.

    It's calculated from the start of treatment until the time of disease progression or the patient's death, whichever comes first.

  4. Overall survival

    Time frame: From the start of treatment until the time of death, assessed up to 120 months.

    It measures the length of time from the start of treatment until the death of the patient from any cause.

  5. Adverse event rate

    Time frame: Within 1 year after completion of radiotherapy.

    It refers to the frequency of treatment related adverse event.

Study contacts

Contact information is provided by the study sponsor or research team.

Guangying Zhu, M.D.

CONTACT

[email protected]

+86 010-84205380

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

Exploration of and Model Establishment of the Regression Pattern of Primary Lesions in Lung Cancer After Definitive Radiotherapy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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