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Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer:Multicenter Controlled Study.(RadimiR-01)

NCT03074175

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer:Multicenter Controlled Study.(RadimiR-01)
  • Official Title: Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer:Multicenter Controlled Study.

Clinical Trial IDs

  • ORG STUDY ID: XQonc-005
  • NCT ID: NCT03074175

Conditions

  • Advanced Nsclc

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
hyperfractionated radiotherapy groupExperimentalAccording to the size of lung lesions,we divided the patients with lesion ≤5cm in diameterand into hyperfractionated radiotherapy group(50Gy/11F/2W).
    conventional fractionated radiotherapy groupExperimentalAccording to the size of lung lesions,we divided the patients with lesion >5cm in diameterand into conventional fractionated radiotherapy group(60Gy/30F/6W).

      Eligibility Criteria

              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.
            
      Maximum Eligible Age:75 Years
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Objective Response Rate(ORR)
      Time Frame:up to two and a half years
      Safety Issue:
      Description:Based on the WHO evaluation criteria for the therapeutic effect of solid tumors, the evaluation of the therapeutic effect was divided into complete remission (CR),partial remission (PR), no change (NC) and progression of disease (PD). The CR + PR meant objective response rate (ORR).

      Secondary Outcome Measures

      Measure:Correlation between the expression level of miRNAs and the ORR.
      Time Frame:up to two and a half years
      Safety Issue:
      Description:Plasma samples were collected in patients with NSCLC before radiotherapy. qRT- PCR was used to detect miRNAs expression in these plasma samples. The correlation between expression of miRNAs and radiotherapy in patients was analyzed and the value of best cut-off miRNA was calculated though receiver operating characteristic (ROC).
      Measure:Progression free survival(PFS)
      Time Frame:up to two and a half years
      Safety Issue:
      Description:According to the follow-up data, whether there is difference in progression free survival (PFS) between miRNAs high expression and miRNAs low expression.
      Measure:side effects of radiation
      Time Frame:up to two and a half years
      Safety Issue:
      Description:According to the follow-up data, whether there is difference in side effects of radiation between hyperfractionated radiotherapy group and conventional fractionated radiotherapy group.
      Measure:quality of life
      Time Frame:up to two and a half years
      Safety Issue:
      Description:According to the follow-up data, whether there is difference in quality of life between hyperfractionated radiotherapy group and conventional fractionated radiotherapy group.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Not yet recruiting
      Lead Sponsor:Xinqiao Hospital of Chongqing

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