Advanced Nsclc Clinical Trial
Official title:
Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer:Multicenter Controlled Study.
Verified date | March 2024 |
Source | Xinqiao Hospital of Chongqing |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Lung cancer is a malignant tumor that causes the highest morbidity and mortality, and the main pathological type is non-small cell lung cancer (NSCLC). Most of them present with advanced stage at diagnosis. Radiotherapy is an important treatment strategy for advanced non-small cell lung cancer. However patients have different responses to radiotherapy due to individual differences, thus there is still lacking of sensitive markers to predict treatment response at present. Using bioinformatics to process the data and small sample clinical trial, our previous study found 5 plasma miRNAs were related to radiosensitivity. The design is controlled clinical trial. According to the size of lung lesions, the investigators divided the patients into hyperfractionated radiotherapy group(50Gy/11F/2W) with lesion ≤5cm in diameter and conventional fractionated radiotherapy group(60Gy/30F/6W)with lesion >5cm in diameter.
Status | Completed |
Enrollment | 240 |
Est. completion date | December 31, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Pathological histology and/or cytology confirmed NSCLC; 2. Based on AJCC Cancer Staging, IIIA, IIIB, IV lung cancer patients with NSCLC; 3. PS 0-2; 4. Expected survival > 3 months; 5. Age 18~75 years old; 6. The function of lung, liver, kidney, bone marrow was normal; 7. The patients had not received radiotherapy for previous primary tumor and metastases; 8. At least accept 2-4 cycles of chemotherapy,not disease progression after chemotherapy,start radiotherapy in two weeks after the last cycle of chemotherapy; 9. Wild-type EGFR; 10. Sensitive mutant EGFR, but refused to targeted therapy; 11. In line with the indications of radiotherapy and accept it; 12. Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent. Exclusion Criteria: 1. Vital organs (e.g., heart, liver, kidney) have serious dysfunction; 2. Patients with other malignancies; 3. Patients with a history of autoimmune disease; 4. The patients are pregnant and lactating (Women of childbearing age need to check the pregnancy test); 5. In the activity of acute or chronic infectious diseases; 6. Patients with a clear history of drug allergy or allergic genus; 7. Patients with participating in other clinical trials at the same time; 8. Other cases that researchers believe that patients should not participate in the present trial. |
Country | Name | City | State |
---|---|---|---|
China | Xinqiao Hospital of Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Xinqiao Hospital of Chongqing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate(ORR) | up to two and a half years | ||
Secondary | Correlation between the expression level of miRNAs and the ORR. | up to two and a half years | ||
Secondary | Progression free survival(PFS) | up to two and a half years | ||
Secondary | side effects of radiation | up to two and a half years |
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