- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074175
Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer:Multicenter Controlled Study.(RadmiR-01)
March 2, 2024 updated by: Jianguo Sun, Xinqiao Hospital of Chongqing
Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer:Multicenter Controlled Study.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: jianguo Sun
- Email: sunjg09@aliyun.com
Study Locations
-
-
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Chongqing, China, 400000
- Xinqiao Hospital of Chongqing
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hyperfractionated radiotherapy group
According to the size of lung lesions,we divided the patients with lesion ≤5cm in diameterand into hyperfractionated radiotherapy group(50Gy/11F/2W).
|
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.
|
Experimental: conventional fractionated radiotherapy group
According to the size of lung lesions,we divided the patients with lesion >5cm in diameterand into conventional fractionated radiotherapy group(60Gy/30F/6W).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Response Rate(ORR)
Time Frame: up to two and a half years
|
up to two and a half years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between the expression level of miRNAs and the ORR.
Time Frame: up to two and a half years
|
up to two and a half years
|
Progression free survival(PFS)
Time Frame: up to two and a half years
|
up to two and a half years
|
side effects of radiation
Time Frame: up to two and a half years
|
up to two and a half years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
March 2, 2017
First Submitted That Met QC Criteria
March 7, 2017
First Posted (Actual)
March 8, 2017
Study Record Updates
Last Update Posted (Estimated)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 2, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XQonc-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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