Stage IV Non-small Cell Lung CancerPhase 2NCT03119519
Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer.
A Phase 2 study testing Local Definitive Radiotherapy and No Local Definitive Radiotherapy in people with Stage IV Non-small Cell Lung Cancer, run by Southern Medical University, China at 1 site in China.
Trial summary
Aggressive therapy may improve survival in synchronous oligometastatic NSCLC and the goal of this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in this subset of patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stage IV Non-small Cell Lung Cancer
- What is being tested?
- Local Definitive Radiotherapy and No Local Definitive Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2017to Sep 2021
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 70 years old;
- Histologically or cytologically confirmed non-small cell lung cancer;
- Stage IV patients with measurable primary tumor and distant metastases number ≤5；
- PS score 0-2；
- Have never received local or systemic anti-cancer treatment, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
- Life expectancy of >3 months;
- Organ function levels must meet the following requirements:
- (1)Bone marrow: White blood cell (WBC)≥4.0G/L；neutrophile granulocyte (NEU)≥1.5G/L；platelets (PLT)≥100G/L; hemoglobin (HGB)≥9g/L； (2)Liver and kidney: total bilirubin (TBIL), aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤2.0 × the upper limit of normal (ULN)；creatinine≤1.5×ULN; 8.Patient must be willing and able to provide written informed consent.
Who cannot join
- The amount of metastatic focus >5;
- Patient can't tolerate chemotherapy or targeted therapy;
- Local or systemic anti-cancer treatment had been used for the primary foci and metastatic lymph nodes, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
- Previous or concurrent suffered from other malignancies;
- Concurrent with other serious disease that can not be controlled;
- Women who are breast-feeding or pregnant;
- Have an allergy to pemetrexed, cisplatin, taxanes, targeted medicine and contrast agent;
- Patients with poor obedience or researchers think that the patient may not be able to accomplish the whole trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Xiaoxia Zhu, M.D., +862062787696, zhuxx01@126.com
About this study
Official title: Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer :A Multicenter,Randomized,Controlled,Phase 2 Study.
Aggressive therapy may improve survival in synchronous oligometastatic NSCLC and the goal of this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in this subset of patients.
Read the detailed description
For NSCLC patients with synchronous oligometastases, first line chemotherapy or targeted therapy concurrent with non-salvage radiotherapy on metastatic or primary thoracic tumor contributed a longer progression-free survival than chemotherapy or targeted therapy alone.
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Being tested
- Local Definitive Radiotherapy, No Local Definitive Radiotherapy
- Keywords
- NSCLC, Oligometastases, 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.
Local Definitive RadiotherapyRadiation
Also called LDR
three-dimensional conformal therapy or intensity modulated radiation therapy
No Local Definitive RadiotherapyDrug
Also called Non-LDR
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
| Study group | Role | What they receive |
|---|---|---|
| Local Definitive Radiotherapy | Experimental | Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) followed by 3D-CRT (three-dimensional conformal radiotherapy) or IMRT (intensity modulated radiotherapy) to primary thoracic foci or remediable oligometastatic focus. Receives: Radiation: Local Definitive Radiotherapy; Drug: No Local Definitive Radiotherapy |
| No Local Definitive Radiotherapy | Active comparator | Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test. Receives: Drug: No Local Definitive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Refers to the time from randomization to disease progression or death.
Measured: 5 years
Secondary outcomes (4)
Local tumor control
From time of randomization to time of progression or death（according to RECIST v1.1 [）
Measured: up to 5 years
Oligometastatic foci control
From time of first chemotherapy or targeted therapy to time of progression or death（according to RECIST v1.1）
Measured: up to 5 years
Thoracic Progression Free Survival
From time of first chemotherapy or targeted therapy to time of progression or death
Measured: up to 5 years
Overall Survival
From time of first chemotherapy or targeted therapy to date of death
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 posted18 Apr 2017
- Study start11 Dec 2017
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized phase II trial of first line chemotherapy or targeted therapy plus local definitive radiotherapy or not for patients with synchronous oligometastatic non-small cell lung cancer
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoxia Zhu, Southern Medical University, China
- Investigators
- Xiaoxia Zhu, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119519
- Sponsor's protocol ID
- LC2019ZD009
- Status last verified
- Mar 2020
- First submitted
- 13 Apr 2017
- Last updated
- 18 Mar 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer :A Multicenter,Randomized,Controlled,Phase 2 Study.
- ClinicalTrials.gov ID
- NCT03119519
- Acronym / sponsor ID
- LC2019ZD009
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Keywords
- NSCLC, Oligometastases, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 18 Apr 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.
Aggressive therapy may improve survival in synchronous oligometastatic NSCLC and the goal of this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in this subset of patients.
Detailed description
For NSCLC patients with synchronous oligometastases, first line chemotherapy or targeted therapy concurrent with non-salvage radiotherapy on metastatic or primary thoracic tumor contributed a longer progression-free survival than chemotherapy or targeted therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized phase II trial of first line chemotherapy or targeted therapy plus local definitive radiotherapy or not for patients with synchronous oligometastatic non-small cell lung cancer
| Arm | Type | Receives |
|---|---|---|
| Local Definitive Radiotherapy | Experimental | Radiation: Local Definitive Radiotherapy, Drug: No Local Definitive RadiotherapyStandard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) followed by 3D-CRT (three-dimensional conformal radiotherapy) or IMRT (intensity modulated radiotherapy) to primary thoracic foci or remediable oligometastatic focus. |
| No Local Definitive Radiotherapy | Active comparator | Drug: No Local Definitive RadiotherapyStandard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged 18 to 70 years old;
- Histologically or cytologically confirmed non-small cell lung cancer;
- Stage IV patients with measurable primary tumor and distant metastases number ≤5；
- PS score 0-2；
- Have never received local or systemic anti-cancer treatment, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
Key exclusion criteria (8 listed)
- The amount of metastatic focus >5;
- Patient can't tolerate chemotherapy or targeted therapy;
- Local or systemic anti-cancer treatment had been used for the primary foci and metastatic lymph nodes, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
- Previous or concurrent suffered from other malignancies;
- Concurrent with other serious disease that can not be controlled;
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 |
|---|---|---|
| Local Definitive RadiotherapyAlso: LDRthree-dimensional conformal therapy or intensity modulated radiation therapy | Radiation | Local Definitive Radiotherapy |
| No Local Definitive RadiotherapyAlso: Non-LDRStandard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test. | Drug | Local Definitive Radiotherapy, No Local Definitive Radiotherapy |
Primary outcome
Progression-free Survival (PFS)
Time frame: 5 years
Refers to the time from randomization to disease progression or death.
4 secondary outcomes
Local tumor control
Time frame: up to 5 years
Oligometastatic foci control
Time frame: up to 5 years
Thoracic Progression Free Survival
Time frame: up to 5 years
Overall Survival
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 18 Mar 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.
Xiaoxia Zhu study chair
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Local Definitive Radiotherapy and No Local Definitive Radiotherapy in people with Stage IV Non-small Cell Lung Cancer, run by Southern Medical University, China 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 8 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: status not confirmed, as of the sponsor's last update on 18 Mar 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaoxia Zhu, M.D. (+862062787696, zhuxx01@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: 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 18 Mar 2020.