Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy

Study Overview
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Brief Summary
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The aim of this randomized study is to investigate pneumonitis, local tumor control, and survival outcomes of primary tumor radiotherapy omitting CTV for patients with advanced NSCLC responded to immunotherapy and chemotherapy

Detailed Description
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Studies have confirmed that systemic therapy combined with primary tumor radiotherapy can improve symptoms and prolong survival of advanced NSCLC. Our previous sturdy indicated that patients who received immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis. Patients suffered grade 2 or more pneumonitis have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for patients treated with immunotherapy and radiotherapy. According to retrospective and prospective studies, omitting primary tumor CTV radiation therapy showed no reduction in local control and survival for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to therapy with immunotherapy and chemotherapy will have less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain better immune function which will facilitate the immunotherapy.

Official Title
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Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy

Conditions
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Advanced Non-Small Cell Squamous Lung Cancer, Radiotherapy, Immunotherapy

Intervention / Treatment
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* Radiation: CTV omitted or delineated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed advanced non-small cell lung cancer (according to the 8th edition of the TNM cancer staging system of AJCC and UICC); After over two cycles of chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend); Age 18 to 80 years old, performance status 0-1; measurable or evaluable lesions; Survival expectancy is not less than 6 months; adequate cardiac, pulmonary, renal, and hepatic and bone marrow function Exclusion Criteria: tumor progress after therapy with immunotherapy and chemotherapy EGFR, ALK, or ROS1 mutation; Previous thoracic radiotherapy; grade 2 or more immune-related adverse events after induction immunotherapy Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ); Pregnant or lactating women undergoing other clinical trials; Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes; Patients with HIV positive and undergoing antiviral therapy; Active tuberculosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTV-omitted<br>CTV was omitted for primary tumor radiotherapy for advanced NSCLC who responded to therapy with immunotherapy and chemotherapy. | Radiation: CTV omitted or delineated<br>* Patients who responded to the therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radiotherapy group or CTV-delineated radiotherapy group.<br>|
| Active Comparator: CTV-delineated<br>CTV was delineated for primary tumor radiotherapy for advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy. | Radiation: CTV omitted or delineated<br>* Patients who responded to the therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radiotherapy group or CTV-delineated radiotherapy group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grade 2 or more pneumonitis |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local/regional control rate |  | up to 12 months | 
| Progress free survival |  | up to 12 months | 
| grade 3 or more pneumonitis |  | up to 6 months | 
| grade 3 or more esophagitis |  | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omitting CTV