Randomized Controlled Clinical Study of Drug Therapy Combined With Thoracic Radiotherapy for Non-oligometastatic NSCLC

NCT05176067 | Unknown

• 1 other identifier: Guizhou MU
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate whether radiotherapy combined with drug therapy is beneficial to non- oligometastatic stage IV NSCLC

Conditions

Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• PFS

  The PFS of primary lung lesions and mediastinal metastatic lymph nodes

  through study completion, an average of 1 year

• ORR

  evaluate efficacy of drug therapy，efficacy of drug combination with radiotherapy with RECIST criteria.

  through study completion, an average of 1-2 years

Secondary Outcomes (1)

• Toxicity and side effecttion

  through study completion, an average of 1-2 years

Study Arms (2)

drug therapy group

NO INTERVENTION

targeted therapy, immune, chemotherapy

drug therapy concurrent radiotherapy

EXPERIMENTAL

drug therapy(targeted therapy, immune, chemotherapy ) combined with thoracic tumor concurrent radiotherapy

Radiation: Thoracic Three-dimensional Radiotherapy

Interventions

Thoracic Three-dimensional Radiotherapy RADIATION

Drug Therapy Combined With Thoracic Three-dimensional Radiotherapy

drug therapy concurrent radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non- small cell lung cancer patients diagnosed by pathology or cytology;
• Patients with stage IV non-oligometastasitatic \[Eighth Edition\];
• initial treatment (no previous treatment);
• age 18 \~ 80 years old, physical condition score ECOG 0 \~ 2 or KPS ≥ 60;
• distance metastatic lesions: more than 5 metastatic lesions ; mind when brain metastases; The number of pulmonary metastases does not affect lung function, and radiotherapy for primary and/or partial metastases may be performed;
• no contraindications such as radiotherapy, EGFR-TKI, chemotherapy, and immunotherapy;
• primary tumor radiotherapy requires IMRT technology; In the plan design, the primary tumor prescription dose (DTGTV) was given under the damage control threshold standard, and the prescription dose was ≥ 40Gy; During the planned evaluation, the prescription dose includes 100% GTV, and 90% prescription dose includes 98% \~ 100% PTV \[planned target dose (DTP) ≥ 36Gy\]; Normal lung (whole lung volume minus GTV volume) V20 ≤ 32%, MLD ≤ 20GY; (V20 ≤ 25% in radiotherapy for patients with ALK, Ros-1, met, etc.).
• radiotherapy for metastatic tumors is three-dimensional radiotherapy technology (IMRT / SRT / SBRT / VMAT, etc.), SBRT.
• the subject has no dysfunction of main organs, or the laboratory test indicators must meet the following requirements: hematology: it is within the normal range according to the standards of each laboratory; Cardiac function: normal range; Liver function: normal range; Renal function: normal range; Pulmonary function: FEV1 \> 50%, mild to moderate impairment of pulmonary function.
• The sign informed consent before treatment (radiotherapy, chemotherapy, immunization, targeted drug therapy);
• patients have good compliance with the treatment and follow-up.

You may not qualify if:

• Stage IV NSCLC patients with serous effusion such as malignant pleural effusion and pericardial effusion;
• Patients with extensive liver metastasis and intrapulmonary metastasis have seriously affected liver and lung function;
• The patient had no control of hypertension, diabetes, unstable angina, history of myocardial infarction, or had congestive heart failure or cardiac arrhythmia in the past 12 months. Heart valve disease with definite clinical diagnosis; Disease activity period of bacterial, fungal, or viral infection; Mental disorders; Severe impairment of pulmonary function;
• Pregnant and lactating patients;
• Patients with a history of other active malignant tumors except for small cell lung cancer before enrollment; Non-melanoma skin basal cell carcinoma, cervical carcinoma in situ and cured early prostate cancer are excluded;
• Patients with the allergic constitution and known or suspected allergy to any drug in the study without alternative drugs;
• Patients with poor compliance;
• The researcher believes that it is not suitable to participate in this experiment

Sponsors & Collaborators

• Guizhou Medical University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bing Lu, bachelor

  Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University

  STUDY CHAIR

Central Study Contacts

Wengang Yang, postgraduate

CONTACT

13984148911; minyangtom@sohu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomized Controlled Clinical Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Model Details: Randomized Controlled Clinical Study

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: January 4, 2022
• Study Start: December 30, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share