Status:
RECRUITING
Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Lead Sponsor:
Hubei Cancer Hospital
Conditions:
Advanced Non-Small Cell Squamous Lung Cancer
Radiotherapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 immu...
Detailed Description
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 recei...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 8 2027
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06037733
Start Date
March 13 2024
End Date
October 8 2027
Last Update
March 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079