Back to resultsPlasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer：Multicenter Controlled Study.(RadimiR-01)
Primary Purpose
Advanced Nsclc
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Nsclc
Eligibility Criteria
Inclusion Criteria:
- Pathological histology and/or cytology confirmed NSCLC;
- Based on AJCC Cancer Staging, IIIA, IIIB, IV lung cancer patients with NSCLC;
- PS 0-2;
- Expected survival > 3 months;
- Age 18~75 years old;
- The function of lung, liver, kidney, bone marrow was normal;
- The patients had not received radiotherapy for previous primary tumor and metastases;
- At least accept 2-4 cycles of chemotherapy,not disease progression after chemotherapy,start radiotherapy in two weeks after the last cycle of chemotherapy;
- Wild-type EGFR;
- Sensitive mutant EGFR, but refused to targeted therapy;
- In line with the indications of radiotherapy and accept it;
- Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.
Exclusion Criteria:
- Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
- Patients with other malignancies;
- Patients with a history of autoimmune disease;
- The patients are pregnant and lactating (Women of childbearing age need to check the pregnancy test);
- In the activity of acute or chronic infectious diseases;
- Patients with a clear history of drug allergy or allergic genus;
- Patients with participating in other clinical trials at the same time;
- Other cases that researchers believe that patients should not participate in the present trial.
Sites / Locations
- Xinqiao Hospital of Chongqing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
hyperfractionated radiotherapy group
conventional fractionated radiotherapy group
Arm Description
According to the size of lung lesions,we divided the patients with lesion ≤5cm in diameterand into hyperfractionated radiotherapy group（50Gy/11F/2W).
According to the size of lung lesions,we divided the patients with lesion >5cm in diameterand into conventional fractionated radiotherapy group（60Gy/30F/6W）.
Outcomes
Primary Outcome Measures
Objective Response Rate（ORR）
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
Correlation between the expression level of miRNAs and the ORR.
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).
Progression free survival（PFS）
According to the follow-up data, whether there is difference in progression free survival (PFS) between miRNAs high expression and miRNAs low expression.
side effects of radiation
According to the follow-up data, whether there is difference in side effects of radiation between hyperfractionated radiotherapy group and conventional fractionated radiotherapy group.
quality of life
According to the follow-up data, whether there is difference in quality of life between hyperfractionated radiotherapy group and conventional fractionated radiotherapy group.
Full Information
NCT ID
NCT03074175
First Posted
March 2, 2017
Last Updated
March 7, 2017
Sponsor
Xinqiao Hospital of Chongqing
1. Study Identification
Unique Protocol Identification Number
NCT03074175
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Nsclc
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hyperfractionated radiotherapy group
Arm Type
Experimental
Arm Description
According to the size of lung lesions,we divided the patients with lesion ≤5cm in diameterand into hyperfractionated radiotherapy group（50Gy/11F/2W).
Arm Title
conventional fractionated radiotherapy group
Arm Type
Experimental
Arm Description
According to the size of lung lesions,we divided the patients with lesion >5cm in diameterand into conventional fractionated radiotherapy group（60Gy/30F/6W）.
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
The patient in supine position with hands catch the plate column by crossing the head, and body fixed by vacuum mould. An enhanced 4DCT scan is conducted with a layer thickness and a distance each of 5 mm. the imaging information is input into the Eclipse program system,the gross tumor volume of the primary tumor (GTVt) and pathological lymph nodes (GTVn) are delineated,GTV is expanded in all 3D direction to create PGTV by 5mm margin for squamous cell carcinoma, or an 8mm margin for adenocarcinoma.Radiaion therapy is delivered by 5F-IMRT.For conventional fractionated radiotherapy,the prescribed dose covering 95% of PGTV is 60Gy/30F/6W.For hyperfractionated radiotherapy,the prescribed dose covering 95% of PGTV is 50Gy/11F/2W.lung V20 <25%, lung V30 <18%, spinal cord <36 Gy.
Primary Outcome Measure Information:
Title
Objective Response Rate（ORR）
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).
Time Frame
up to two and a half years
Secondary Outcome Measure Information:
Title
Correlation between the expression level of miRNAs and the ORR.
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).
Time Frame
up to two and a half years
Title
Progression free survival（PFS）
Description
According to the follow-up data, whether there is difference in progression free survival (PFS) between miRNAs high expression and miRNAs low expression.
Time Frame
up to two and a half years
Title
side effects of radiation
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.
Time Frame
up to two and a half years
Title
quality of life
Description
According to the follow-up data, whether there is difference in quality of life between hyperfractionated radiotherapy group and conventional fractionated radiotherapy group.
Time Frame
up to two and a half years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathological histology and/or cytology confirmed NSCLC;
Based on AJCC Cancer Staging, IIIA, IIIB, IV lung cancer patients with NSCLC;
PS 0-2;
Expected survival > 3 months;
Age 18~75 years old;
The function of lung, liver, kidney, bone marrow was normal;
The patients had not received radiotherapy for previous primary tumor and metastases;
At least accept 2-4 cycles of chemotherapy,not disease progression after chemotherapy,start radiotherapy in two weeks after the last cycle of chemotherapy;
Wild-type EGFR;
Sensitive mutant EGFR, but refused to targeted therapy;
In line with the indications of radiotherapy and accept it;
Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.
Exclusion Criteria:
Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
Patients with other malignancies;
Patients with a history of autoimmune disease;
The patients are pregnant and lactating (Women of childbearing age need to check the pregnancy test);
In the activity of acute or chronic infectious diseases;
Patients with a clear history of drug allergy or allergic genus;
Patients with participating in other clinical trials at the same time;
Other cases that researchers believe that patients should not participate in the present trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianguo Sun
Email
sunjg09@aliyun.com
Facility Information:
Facility Name
Xinqiao Hospital of Chongqing
City
Chongqing
ZIP/Postal Code
400000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer：Multicenter Controlled Study.(RadimiR-01)
We'll reach out to this number within 24 hrs