The Regression Pattern of Primary Lesions in Lung Cancer After Definitive Radiotherapy

NCT06692972 | Recruiting

• 1 other identifier: 2024-ZF-38
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

lung cancer; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Tumor regression rate

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

  Within 1 year after completion of radiotherapy.

Secondary Outcomes (5)

• Objective response rate

  Within 1 year after completion of radiotherapy.

• Disease control rate

  Within 1 year after completion of radiotherapy.

• Progression-free survival

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

• Overall survival

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

• Adverse event rate

  Within 1 year after completion of radiotherapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage II-III lung cancer patients who have received definitive radiotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (2)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Guangying Zhu, M.D.

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangying Zhu, M.D.

CONTACT

+86 010-84205380; zryyfa@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Chief Physician

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: December 25, 2024
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available starting 1 year and ending 4 years following article publication.
• Access Criteria: The data will be made available upon request for researchers who provide a methodologically sound proposal. The data will be accessible for non-commercial research purposes only and will be used to explore additional hypotheses related to the study's objectives.

Locations

CN (2)