Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Recruiting · NCT06037733 · Interventional (participants receive a specific treatment) · Lead sponsor: Hubei Cancer Hospital
View the official record on ClinicalTrials.gov →Interventions studied
CTV omitted or delineated
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Hubei Cancer Hospital - Wuhan, Hubei, China