Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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Simultaneous radiotherapy followed by adjuvant immunotherapy is the standard treatment modality of unresectable stage III NSCLC. Our preliminary study confirmed that the treatment of CTV-omitted IMRT regimen did not compromise the PFS or OS and significantly reduced the incidence of severe radiation pneumonia and radiation esophagitis. The purpose of this study was to observe the role of radiotherapy modalities that omit CTV in the context of immunotherapy for NSCLC.

Official Title
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Feasibility of Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer

Conditions
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Immunotherapy, Intensity Modulated Radiation Therapy, Radiotherapy, NSCLC

Intervention / Treatment
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* Radiation: IMRT+adjuvant immunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •Patients with advanced (Stage IIIA or IIIB AJCC 7) NSCLC that was histologically or cytologically inoperable ECOG whole body status (performancestatus,PS) level 0 or 1 The estimated survival time is more than 12 weeks, 18  80 years old Laboratory results within 2 weeks prior to radiotherapy met the following criteria: ① Neutrophil count > 1,500/ MCL Heathko-Pilot Oncology Research Fund; ② Platelet > 50,000/ MCL; ③ Total bilirubin < 1.5 times of the normal upper limit value; ④AST(SGOT)/ALT(SGPT) < 2.5 times of the normal upper limit; ⑤ Serum creatinine < 1.5 times of the normal upper limit value; ⑥ The results of coagulation function examination were within the normal range Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before admission, and the results are negative, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug Understand and voluntarily sign written informed consent The investigator judged that the patient had good compliance Exclusion Criteria: Malignant pleural/pericardial effusions, previous thoracic radiotherapy or chemotherapy Uncontrolled concurrent diseases, including but not limited to symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, uncontrolled diabetic blood sugar, arrhythmia, mental illness or social condition, etc. Pregnant or nursing women The patient has no history of intracranial hemorrhage or spinal cord hemorrhage HIV-positive patients receiving combination antiretroviral therapy Active tuberculosis Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study Prior allogeneic stem cell or solid organ transplantation Researchers determine other conditions that may affect the conduct of clinical studies and the determination of their findings

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>CTV-omitted IMRT+adjuvant immunotherapy | Radiation: IMRT+adjuvant immunotherapy<br>* The enrollment was randomly (1:1) assigned into the study group with CTV-omitted IMRT and the control group with CTV-delineated IMRT using a random number table.<br>|
| control group<br>CTV-delineated IMRT+adjuvant immunotherapy | Radiation: IMRT+adjuvant immunotherapy<br>* The enrollment was randomly (1:1) assigned into the study group with CTV-omitted IMRT and the control group with CTV-delineated IMRT using a random number table.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | The time between randomization and the first occurrence of disease progression or die | through study completion，up to 12 weeks | 
| radiation respiratory events or esophagitis with grade 3 or higher |  | after radiation therapy，up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from randomization to death from any cause | through study completion, an average of 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IMRT, immunotherapy, CTV