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

Department of Thoracic Oncology, Affiliated Tumor Hospital of Guizhou Medical University

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stage IV Non-small Cell Lung Cancer
• Intervention / Treatment: Radiation: Thoracic Three-dimensional Radiotherapy

Detailed Description

Group A (targeted therapy, immunotherapy, chemotherapy); The efficacy was evaluated after the second and fourth cycles of chemotherapy and immunotherapy; The efficacy of targeted therapy was evaluated every month; Group B (drug concurrent radiotherapy group: combined with thoracic primary tumor radiotherapy on the basis of targeted therapy, immune, chemotherapy ) The efficacy was evaluated after the second and fourth cycles of chemotherapy and immunotherapy; The efficacy of targeted therapy was evaluated every month; Radiographic evaluation was performed after radiotherapy for the primary lesion of the chest.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wengang Yang, postgraduate; Phone Number: 13984148911; Email: minyangtom@sohu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Non- small cell lung cancer patients diagnosed by pathology or cytology;
2. Patients with stage IV non-oligometastasitatic [Eighth Edition];
3. initial treatment (no previous treatment);
4. age 18 ~ 80 years old, physical condition score ECOG 0 ~ 2 or KPS ≥ 60;
5. 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;
6. no contraindications such as radiotherapy, EGFR-TKI, chemotherapy, and immunotherapy;
7. 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.).
8. radiotherapy for metastatic tumors is three-dimensional radiotherapy technology (IMRT / SRT / SBRT / VMAT, etc.), SBRT.
9. 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.
10. The sign informed consent before treatment (radiotherapy, chemotherapy, immunization, targeted drug therapy);
11. patients have good compliance with the treatment and follow-up.

Exclusion Criteria:

1. Patients with pathological type, stage, and survival status that do not meet the inclusion criteria;
2. Stage IV NSCLC patients with serous effusion such as malignant pleural effusion and pericardial effusion;
3. Patients with extensive liver metastasis and intrapulmonary metastasis have seriously affected liver and lung function;
4. 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;
5. Pregnant and lactating patients;
6. 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;
7. Patients with the allergic constitution and known or suspected allergy to any drug in the study without alternative drugs;
8. Patients with poor compliance;
9. The researcher believes that it is not suitable to participate in this experiment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: drug therapy group; targeted therapy, immune, chemotherapy
Experimental: drug therapy concurrent radiotherapy; drug therapy(targeted therapy, immune, chemotherapy ) combined with thoracic tumor concurrent radiotherapy	Radiation: Thoracic Three-dimensional Radiotherapy; Drug Therapy Combined With Thoracic Three-dimensional Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity and side effecttion	CTC5.0 standard was used to evaluate toxicity and side effects caused by drug therapy and radiotherapy.such as Pulmonary toxicity,Hematological toxicity,esophagitis.	through study completion, an average of 1-2 years

Collaborators and Investigators

• Sponsor: Guizhou Medical University
• Investigators: Study Chair: Bing Lu, bachelor, Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 30, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 27, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: Guizhou MU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No