Stage IV Non-small Cell Lung CancerNCT05176067
Randomized Controlled Clinical Study of Drug Therapy Combined With Thoracic Radiotherapy for Non-oligometastatic NSCLC
A study testing Thoracic Three-dimensional Radiotherapy in people with Stage IV Non-small Cell Lung Cancer, run by Guizhou Medical University.
Trial summary
To investigate whether radiotherapy combined with drug therapy is beneficial to non- oligometastatic stage IV NSCLC Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stage IV Non-small Cell Lung Cancer
- What is being tested?
- Thoracic Three-dimensional Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2021to 31 Dec 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non- small cell lung cancer patients diagnosed by pathology or cytology;
- Patients with stage IV non-oligometastasitatic [Eighth Edition];
- initial treatment (no previous treatment);
- age 18 ~ 80 years old, physical condition score ECOG 0 ~ 2 or KPS ≥ 60;
- distance metastatic lesions: more than 5 metastatic lesions ; mind when brain metastases; The number of pulmonary metastases does not affect lung function, and radiotherapy for primary and/or partial metastases may be performed;
- no contraindications such as radiotherapy, EGFR-TKI, chemotherapy, and immunotherapy;
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- primary tumor radiotherapy requires IMRT technology; In the plan design, the primary tumor prescription dose (DTGTV) was given under the damage control threshold standard, and the prescription dose was ≥ 40Gy; During the planned evaluation, the prescription dose includes 100% GTV, and 90% prescription dose includes 98% ~ 100% PTV [planned target dose (DTP) ≥ 36Gy]; Normal lung (whole lung volume minus GTV volume) V20 ≤ 32%, MLD ≤ 20GY; (V20 ≤ 25% in radiotherapy for patients with ALK, Ros-1, met, etc.).
- radiotherapy for metastatic tumors is three-dimensional radiotherapy technology (IMRT / SRT / SBRT / VMAT, etc.), SBRT.
- the subject has no dysfunction of main organs, or the laboratory test indicators must meet the following requirements: hematology: it is within the normal range according to the standards of each laboratory; Cardiac function: normal range; Liver function: normal range; Renal function: normal range; Pulmonary function: FEV1 > 50%, mild to moderate impairment of pulmonary function.
- The sign informed consent before treatment (radiotherapy, chemotherapy, immunization, targeted drug therapy);
- patients have good compliance with the treatment and follow-up.
Who cannot join
- Patients with pathological type, stage, and survival status that do not meet the inclusion criteria;
- Stage IV NSCLC patients with serous effusion such as malignant pleural effusion and pericardial effusion;
- Patients with extensive liver metastasis and intrapulmonary metastasis have seriously affected liver and lung function;
- The patient had no control of hypertension, diabetes, unstable angina, history of myocardial infarction, or had congestive heart failure or cardiac arrhythmia in the past 12 months. Heart valve disease with definite clinical diagnosis; Disease activity period of bacterial, fungal, or viral infection; Mental disorders; Severe impairment of pulmonary function;
- Pregnant and lactating patients;
- Patients with a history of other active malignant tumors except for small cell lung cancer before enrollment; Non-melanoma skin basal cell carcinoma, cervical carcinoma in situ and cured early prostate cancer are excluded;
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- Patients with the allergic constitution and known or suspected allergy to any drug in the study without alternative drugs;
- Patients with poor compliance;
- The researcher believes that it is not suitable to participate in this experiment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Department of Thoracic Oncology, Affiliated Tumor Hospital of Guizhou Medical University
To investigate whether radiotherapy combined with drug therapy is beneficial to non- oligometastatic stage IV NSCLC
Read the detailed description
Group A (targeted therapy, immunotherapy, chemotherapy); The efficacy was evaluated after the second and fourth cycles of chemotherapy and immunotherapy; The efficacy of targeted therapy was evaluated every month; Group B (drug concurrent radiotherapy group: combined with thoracic primary tumor radiotherapy on the basis of targeted therapy, immune, chemotherapy ) The efficacy was evaluated after the second and fourth cycles of chemotherapy and immunotherapy; The efficacy of targeted therapy was evaluated every month; Radiographic evaluation was performed after radiotherapy for the primary lesion of the chest.
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Being tested
- Thoracic Three-dimensional Radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Three-dimensional RadiotherapyRadiation
Drug Therapy Combined With Thoracic Three-dimensional Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| drug therapy group | No intervention | targeted therapy, immune, chemotherapy |
| drug therapy concurrent radiotherapy | Experimental | drug therapy(targeted therapy, immune, chemotherapy ) combined with thoracic tumor concurrent radiotherapy Receives: Radiation: Thoracic Three-dimensional Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The PFS of primary lung lesions and mediastinal metastatic lymph nodes
Measured: through study completion, an average of 1 year
ORR
evaluate efficacy of drug therapy，efficacy of drug combination with radiotherapy with RECIST criteria.
Measured: through study completion, an average of 1-2 years
Secondary outcomes (1)
Toxicity and side effecttion
CTC5.0 standard was used to evaluate toxicity and side effects caused by drug therapy and radiotherapy.such as Pulmonary toxicity,Hematological toxicity,esophagitis.
Measured: through study completion, an average of 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start30 Dec 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Non-small Cell Lung CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Clinical Study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Lu, Guizhou Medical University
- Investigators
- Bing Lu, bachelor, Study chair, Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176067
- Sponsor's protocol ID
- Guizhou MU
- Status last verified
- Dec 2021
- First submitted
- 27 Nov 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Thoracic Oncology, Affiliated Tumor Hospital of Guizhou Medical University
- ClinicalTrials.gov ID
- NCT05176067
- Acronym / sponsor ID
- Guizhou MU
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Jan 2022 (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.
To investigate whether radiotherapy combined with drug therapy is beneficial to non- oligometastatic stage IV NSCLC
Detailed description
Group A (targeted therapy, immunotherapy, chemotherapy); The efficacy was evaluated after the second and fourth cycles of chemotherapy and immunotherapy; The efficacy of targeted therapy was evaluated every month; Group B (drug concurrent radiotherapy group: combined with thoracic primary tumor radiotherapy on the basis of targeted therapy, immune, chemotherapy ) The efficacy was evaluated after the second and fourth cycles of chemotherapy and immunotherapy; The efficacy of targeted therapy was evaluated every month; Radiographic evaluation was performed after radiotherapy for the primary lesion of the chest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Clinical Study
| Arm | Type | Receives |
|---|---|---|
| drug therapy group | No intervention | –targeted therapy, immune, chemotherapy |
| drug therapy concurrent radiotherapy | Experimental | Radiation: Thoracic Three-dimensional Radiotherapydrug therapy(targeted therapy, immune, chemotherapy ) combined with thoracic tumor concurrent radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Non- small cell lung cancer patients diagnosed by pathology or cytology;
- Patients with stage IV non-oligometastasitatic [Eighth Edition];
- initial treatment (no previous treatment);
- age 18 ~ 80 years old, physical condition score ECOG 0 ~ 2 or KPS ≥ 60;
- distance metastatic lesions: more than 5 metastatic lesions ; mind when brain metastases; The number of pulmonary metastases does not affect lung function, and radiotherapy for primary and/or partial metastases may be performed;
Key exclusion criteria (9 listed)
- Patients with pathological type, stage, and survival status that do not meet the inclusion criteria;
- Stage IV NSCLC patients with serous effusion such as malignant pleural effusion and pericardial effusion;
- Patients with extensive liver metastasis and intrapulmonary metastasis have seriously affected liver and lung function;
- The patient had no control of hypertension, diabetes, unstable angina, history of myocardial infarction, or had congestive heart failure or cardiac arrhythmia in the past 12 months. Heart valve disease with definite clinical diagnosis; Disease activity period of bacterial, fungal, or viral infection; Mental disorders; Severe impairment of pulmonary function;
- Pregnant and lactating patients;
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 |
|---|---|---|
| Thoracic Three-dimensional RadiotherapyDrug Therapy Combined With Thoracic Three-dimensional Radiotherapy | Radiation | drug therapy concurrent radiotherapy |
Primary outcome
PFS
Time frame: through study completion, an average of 1 year
The PFS of primary lung lesions and mediastinal metastatic lymph nodes
ORR
Time frame: through study completion, an average of 1-2 years
evaluate efficacy of drug therapy，efficacy of drug combination with radiotherapy with RECIST criteria.
1 secondary outcome
Toxicity and side effecttion
Time frame: through study completion, an average of 1-2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Bing Lu, bachelor study chair
Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Three-dimensional Radiotherapy in people with Stage IV Non-small Cell Lung Cancer, run by Guizhou Medical University.
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 11 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wengang Yang, postgraduate (13984148911, minyangtom@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 4 Jan 2022.