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

Not Applicable

Completed

• Conditions: Advanced Nsclc
• Interventions: Radiation: radiotherapy

• Registration Number: NCT03074175
• Lead Sponsor: Xinqiao Hospital of Chongqing

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-08
• Study Start: 2017-07-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-02
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyperfractionated radiotherapy group	radiotherapy	According 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 group	radiotherapy	According to the size of lung lesions,we divided the patients with lesion \>5cm in diameterand into conventional fractionated radiotherapy group（60Gy/30F/6W）.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate（ORR）	up to two and a half years

Secondary Outcome Measures

Name	Time	Method
Progression free survival（PFS）	up to two and a half years
Correlation between the expression level of miRNAs and the ORR.	up to two and a half years
side effects of radiation	up to two and a half years

Trial Locations

Locations (1)

Xinqiao Hospital of Chongqing; 🇨🇳 Chongqing, China