RecruitingNot ApplicableNCT06037733
Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy
Sponsor
Hubei Cancer Hospital
Enrollment
134 participants
Start Date
Mar 13, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- 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 Criteria10
- 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
Interventions
RADIATIONCTV omitted or delineated
Patients who responded to the therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radiotherapy group or CTV-delineated radiotherapy group.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06037733
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