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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074175
• Other study ID #: XQonc-005
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2024
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Advanced Nsclc
• Carcinoma, Non-Small-Cell Lung

Intervention

Radiation:
• radiotherapy
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.

Locations

Country	Name	City	State
China	Xinqiao Hospital of Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

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