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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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.
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）.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinqiao Hospital of Chongqing

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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