Actively Recruiting
Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Led by Hubei Cancer Hospital · Updated on 2024-03-15
134
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed non-small cell lung cancer
- Stage IIIA, IIIB, or IIIC according to the 8th edition of the TNM cancer staging system
- Inoperable or refuses surgery after induction therapy with immunotherapy and chemoradiotherapy
- After 2 or more cycles of induction chemotherapy combined with immunotherapy, efficacy was complete response, partial response, or stable disease with a decreasing trend
- Performance status of 0 or 1
- Measurable or evaluable lesions
- Survival expectancy of at least 6 months
- Adequate cardiac, pulmonary, renal, hepatic, and bone marrow function
You will not qualify if you...
- Tumor progression after induction immunotherapy and chemotherapy
- Presence of EGFR, ALK, or ROS1 mutation
- Previous thoracic radiotherapy
- Grade 2 or higher immune-related adverse events after induction immunotherapy
- Previous malignancies except stage I non-melanoma skin cancer or cervical carcinoma in situ
- Pregnant or lactating women
- Currently participating in other clinical trials
- Serious comorbidities such as myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis, or uncontrolled diabetes
- HIV positive and undergoing antiviral therapy
- Active tuberculosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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