Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy

Study Overview
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Brief Summary
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Radical radiotherapy is critical for locally advanced non small cell lung cancer(NSCLC ). Our previous sturdy indicated that patients who received induction immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis.Grade 2 or more pneumonitis patients 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 CTV radiation is feasible for patients undergoing concurrent radio-chemotherapy for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to induction 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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Omitting CTV Radiotherapy for Locally Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Radiotherapy

Conditions
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Non Small Cell Lung Cancer, Locally Advanced, 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 non-small cell lung cancer; stage IIIA or IIIB or IIIC according to the 8th edition of the TNM cancer staging system of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control（UICC); inoperable or refuses surgery after induction therapy with immunotherapy and chemoradiotherapy; After ≥2 cycles of induction chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend); 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 induction with immunothearoy 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: Treatment
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 the radical radiotherapy for locally advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy. | Radiation: CTV omitted or delineated<br>* Patients who responded to the induction therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radical radiotherapy group or CTV-delineated radiotherapy group.<br>|
| Active Comparator: CTV-delineated<br>CTV was delineated for the radical radiotherapy for locally advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy. | Radiation: CTV omitted or delineated<br>* Patients who responded to the induction therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radical 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