RadiotherapyNCT04654520
A Randomized Study of Primary Tumor Radiotherapy for Patients With Stage Ⅳ NSCLC
A study testing Drug therapy concurrent radiotherapy for primary tumor omitted CTV in people with Radiotherapy and Nonsmall Cell Lung Cancer, Stage IV, run by Guizhou Medical University at 1 site in China.
Trial summary
The aim of this randomized study is to investigate local tumor control, survival outcomes,and complications on patients of stage Ⅳ non small-cell lung cancer ,whom based on medication with concurrent primary radiotherapy omitting clinical tumor volume. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiotherapy, Nonsmall Cell Lung Cancer, Stage IV
- What is being tested?
- Drug therapy concurrent radiotherapy for primary tumor omitted CTV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2020to 31 May 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathological or cytological diagnosis, stage IV [UICC 2017 staging eighth edition] NSCLC patients;
- initial treatment (previously did not receive any treatment), it is recommended to complete the detection of driver genes (EGFR / ALK / ROS1) (tissue, blood);
- Age 18 to 80 years old, physical status score ECOG 0 to 2 or KPS ≥ 70 (see Annex 2); Metastatic lesions in the distant area: conscious when brain metastasis; the number of metastatic lesions in the lung does not affect lung function and may be treated with primary and/or partial metastases;
- no radiotherapy, targeted drug therapy and chemotherapy contraindications;
- primary tumor radiotherapy requires IMRT technology;
- Plan the design to give the primary tumor prescription dose (DTGTV) under the damage control threshold criteria;
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- The planned dose includes 100% GTV, 90% of the prescribed dose includes 98%~100% of PTV [planned target dose (DTPTV)]; normal lung (full lung volume minus GTV volume) V20 ≤ 32%, MLD≤20Gy;
- metastatic tumor radiotherapy is a three-dimensional radiotherapy technique (IMRT/SRT/SBRT/VMAT, etc.), and large-segment radiotherapy.
- Subjects have no major organ dysfunction, or laboratory test indicators must meet the following requirements: Hematology: normal range according to laboratory standards; cardiac function: normal range; liver function: normal range; renal function: normal range Lung function: FEV1>50%, impaired light-moderate lung function.
- Informed consent (radiation, medication) before treatment;
- The patient has good compliance with the treatment and follow-up received.
Who cannot join
- Patients who do not meet the pathological type, stage, and survival status of the inclusion criteria;
- patients with malignant pericardial effusion; Diffuse liver metastasis, intrapulmonary metastasis and has seriously affected patients with liver and lung function;
- Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, or symptomatic congestive heart failure or uncontrolled arrhythmias in the past 12 months; clinically diagnosed heart valve disease;
- Active period of disease caused by bacteria, fungi or viruses; mental disorders; impaired severe lung function;
- pregnant, lactating patients;
- Patients with a history of other active malignancies other than small cell lung cancer before entering the group; non-melanoma skin basal cell carcinoma, in situ cervical cancer, and cured early prostate cancer;
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- Patients with allergies and no known alternatives to known or suspected drugs in any study;
- Patients with poor compliance;
- Researchers believe that it is not appropriate to participate in this test.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001
About this study
Official title: A Randomized Study of Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Stage Ⅳ NSCLC
The aim of this randomized study is to investigate local tumor control, survival outcomes,and complications on patients of stage Ⅳ non small-cell lung cancer ,whom based on medication with concurrent primary radiotherapy omitting clinical tumor volume.
Read the detailed description
Cancer Statistics,（2020）states that low lung cancer survival rates reflect the large proportion of patients (57%) diagnosed with metastatic disease, for which the 5-year relative survival rate is 5%.With the development of three-dimensional radiotherapy technology, the wide application of comprehensive treatment concept, and the understanding of the relationship between different metastatic state and survival of stage IV NSCLC, prospective and retrospective studies have confirmed that systemic therapy combined with primary tumor three-dimensional radiation Treatment is more conducive to improving symptoms and prolonging survival than medication alone. Some retrospective analysises of stage III NSCLC, omitting clinical target volume of primary tumor with intensity modulated radiotherapy showed no reduction in local control rate and survival time.Omitted CTV in Ⅳ NSCLC patients with primary tumor radiotherapy can make smaller target area, which could push up most of the local stage of late Ⅳ NSCLC patients with primary tumor radiation dose. Prospective studies are needed to further clarify whether omission of target areas may affect local control time, survival time, and radioactive toxicity.
- Conditions
- Radiotherapy, Nonsmall Cell Lung Cancer, Stage IV
- Being tested
- Drug therapy concurrent radiotherapy for primary tumor omitted CTV
- 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.
Drug therapy concurrent radiotherapy for primary tumor omitted CTVOther
Thoracic intensity modulated radiotherapy for primary tumor omitted CTV+Chemotherapy or Targeted drug therapy
| Study group | Role | What they receive |
|---|---|---|
| Drug therapy combined with radiotherapy for primary tumor omitted CTV | Experimental | * IMRT (omitted CTV) concurrent with systemic chemotherapy on paticipants of kown negative gene mutation .After it, the paticipants may choose immunotherapy.
* IMRT (omitted CTV) concurrent with targeted drug on paticipants of kown sensitive gene mutation. Receives: Other: Drug therapy concurrent radiotherapy for primary tumor omitted CTV |
| Drug therapy combined with radiotherapy for primary tumor with CTV | No intervention | * IMRT (with CTV) concurrent with systemic chemotherapy on paticipants of kown negative gene mutation .After it, the paticipants may choose immunotherapy. * IMRT ((with CTV) concurrent with targeted drug on paticipants of kown sensitive gene mutation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local regional progression-free survival（LRPFS）
LRPFS is defined as the duration of time from start of treatment to time of progression or recurrence, whichever occurs first.The target lesions is only for primary tumor and regional positive lymph nodes.
Measured: Up to 5 years
Secondary outcomes (3)
Overall survival (OS)
Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.
Measured: Up to 5 years
Progression-free survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: Up to 5 years
Adverse events (toxicities)
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start15 Dec 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies 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
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bing Lu, Bachelor, Principal investigator, The Affiliated Hospital Of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654520
- Sponsor's protocol ID
- Ⅳ-NSCLC-OCTV
- Status last verified
- Nov 2020
- First submitted
- 29 Nov 2020
- Last updated
- 4 Dec 2020
- 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 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Stage Ⅳ NSCLC
- ClinicalTrials.gov ID
- NCT04654520
- Acronym / sponsor ID
- Ⅳ-NSCLC-OCTV
- Conditions
- Radiotherapy, Nonsmall Cell Lung Cancer, Stage IV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 4 Dec 2020 (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.
The aim of this randomized study is to investigate local tumor control, survival outcomes,and complications on patients of stage Ⅳ non small-cell lung cancer ,whom based on medication with concurrent primary radiotherapy omitting clinical tumor volume.
Detailed description
Cancer Statistics,（2020）states that low lung cancer survival rates reflect the large proportion of patients (57%) diagnosed with metastatic disease, for which the 5-year relative survival rate is 5%.With the development of three-dimensional radiotherapy technology, the wide application of comprehensive treatment concept, and the understanding of the relationship between different metastatic state and survival of stage IV NSCLC, prospective and retrospective studies have confirmed that systemic therapy combined with primary tumor three-dimensional radiation Treatment is more conducive to improving symptoms and prolonging survival than medication alone. Some retrospective analysises of stage III NSCLC, omitting clinical target volume of primary tumor with intensity modulated radiotherapy showed no reduction in local control rate and survival time.Omitted CTV in Ⅳ NSCLC patients with primary tumor radiotherapy can make smaller target area, which could push up most of the local stage of late Ⅳ NSCLC patients with primary tumor radiation dose. Prospective studies are needed to further clarify whether omission of target areas may affect local control time, survival time, and radioactive toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug therapy combined with radiotherapy for primary tumor omitted CTV | Experimental | Other: Drug therapy concurrent radiotherapy for primary tumor omitted CTV* IMRT (omitted CTV) concurrent with systemic chemotherapy on paticipants of kown negative gene mutation .After it, the paticipants may choose immunotherapy. * IMRT (omitted CTV) concurrent with targeted drug on paticipants of kown sensitive gene mutation. |
| Drug therapy combined with radiotherapy for primary tumor with CTV | No intervention | –* IMRT (with CTV) concurrent with systemic chemotherapy on paticipants of kown negative gene mutation .After it, the paticipants may choose immunotherapy. * IMRT ((with CTV) concurrent with targeted drug on paticipants of kown sensitive gene mutation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with pathological or cytological diagnosis, stage IV [UICC 2017 staging eighth edition] NSCLC patients;
- initial treatment (previously did not receive any treatment), it is recommended to complete the detection of driver genes (EGFR / ALK / ROS1) (tissue, blood);
- Age 18 to 80 years old, physical status score ECOG 0 to 2 or KPS ≥ 70 (see Annex 2); Metastatic lesions in the distant area: conscious when brain metastasis; the number of metastatic lesions in the lung does not affect lung function and may be treated with primary and/or partial metastases;
- no radiotherapy, targeted drug therapy and chemotherapy contraindications;
- primary tumor radiotherapy requires IMRT technology;
Key exclusion criteria (9 listed)
- Patients who do not meet the pathological type, stage, and survival status of the inclusion criteria;
- patients with malignant pericardial effusion; Diffuse liver metastasis, intrapulmonary metastasis and has seriously affected patients with liver and lung function;
- Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, or symptomatic congestive heart failure or uncontrolled arrhythmias in the past 12 months; clinically diagnosed heart valve disease;
- Active period of disease caused by bacteria, fungi or viruses; mental disorders; impaired severe lung function;
- pregnant, 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 |
|---|---|---|
| Drug therapy concurrent radiotherapy for primary tumor omitted CTVThoracic intensity modulated radiotherapy for primary tumor omitted CTV+Chemotherapy or Targeted drug therapy | Other | Drug therapy combined with radiotherapy for primary tumor omitted CTV |
Primary outcome
Local regional progression-free survival（LRPFS）
Time frame: Up to 5 years
LRPFS is defined as the duration of time from start of treatment to time of progression or recurrence, whichever occurs first.The target lesions is only for primary tumor and regional positive lymph nodes.
3 secondary outcomes
Overall survival (OS)
Time frame: Up to 5 years
Progression-free survival (PFS)
Time frame: Up to 5 years
Adverse events (toxicities)
Time frame: Up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- 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 principal investigator
The Affiliated Hospital Of Guizhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug therapy concurrent radiotherapy for primary tumor omitted CTV in people with Radiotherapy and Nonsmall Cell Lung Cancer, Stage IV, run by Guizhou Medical University 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 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 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bing Lu, Bachelor (13809432527, lbgymaaaa@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local regional progression-free survival（LRPFS） (time frame: Up to 5 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 4 Dec 2020.