Advanced NsclcNCT03074175
Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer：Multicenter Controlled Study.(RadmiR-01)
A study testing radiotherapy in people with Advanced Nsclc, run by Xinqiao Hospital of Chongqing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Nsclc
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Advanced Nsclc
- Being tested
- radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| hyperfractionated radiotherapy group | Experimental | According to the size of lung lesions,we divided the patients with lesion ≤5cm in diameterand into hyperfractionated radiotherapy group（50Gy/11F/2W). Receives: Radiation: radiotherapy |
| conventional fractionated radiotherapy group | Experimental | According to the size of lung lesions,we divided the patients with lesion >5cm in diameterand into conventional fractionated radiotherapy group（60Gy/30F/6W）. Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
Measured: up to two and a half years
Secondary outcomes (3)
Correlation between the expression level of miRNAs and the ORR.
Measured: up to two and a half years
Progression free survival（PFS）
Measured: up to two and a half years
side effects of radiation
Measured: up to two and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Jul 2017
- Primary completion1 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced NsclcStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074175
- Sponsor's protocol ID
- XQonc-005
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2017
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer：Multicenter Controlled Study.
- ClinicalTrials.gov ID
- NCT03074175
- Acronym / sponsor ID
- XQonc-005
- Conditions
- Advanced Nsclc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperfractionated radiotherapy group | Experimental | Radiation: radiotherapyAccording 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 | Experimental | Radiation: radiotherapyAccording to the size of lung lesions,we divided the patients with lesion >5cm in diameterand into conventional fractionated radiotherapy group（60Gy/30F/6W）. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapyThe 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. | Radiation | conventional fractionated radiotherapy group, hyperfractionated radiotherapy group |
Primary outcome
Objective Response Rate（ORR）
Time frame: up to two and a half years
3 secondary outcomes
Correlation between the expression level of miRNAs and the ORR.
Time frame: up to two and a half years
Progression free survival（PFS）
Time frame: up to two and a half years
side effects of radiation
Time frame: up to two and a half years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiotherapy in people with Advanced Nsclc, run by Xinqiao Hospital of Chongqing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate（ORR） (time frame: up to two and a half years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.