Non Small Cell Lung CancerNCT05647590
SBRT/RT in Oligometastatic Stage IV NSCLC
A study testing Chemotherapy, Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT) and Maintenance chemotherapy in people with Non Small Cell Lung Cancer, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 10 metastatic sites will improve progression-free survival (PFS) with acceptable toxicity compared to maintenance chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Chemotherapy, Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT) and Maintenance chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2019to 31 Dec 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have biopsy-proven metastatic NSCLC (Stage IV).
- Patients must have received three months of first-line chemotherapy and achieved stable disease or partial response.
- Age ≥ 18 years
- Patients must have measurable disease at baseline.
- Patients can have up to 10 discrete active extracranial/intracranial lesions identified by PET/CT or MRI scan within 8 weeks prior to the initiation of SBRT.
- Patients must have a Karnofsky Performance Scale (KPS) >60
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- AST, ALT \& Alkaline phosphates must be ≤ 2.5x the upper limit of normal. Total bilirubin must be within the limit of normal.
- Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
- Patients should have adequate renal function (serum creatinine ≤1.5 times the upper limit of normal (ULN).
- Females of childbearing potential should have a negative pregnancy test.
- Patients who would be receiving SBRT for lung tumors must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.
- Patients must provide verbal and written informed consent to participate in the study
Who cannot join
- Patients receiving first-line erlotinib, gefitinib, or crizotinib for EGFR mutant-positive or EML4-ALK-positive NSCLC will be excluded.
- Patients who previously received radiotherapy at the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy
- Patients with serious, uncontrolled, concurrent infection(s)
- Significant weight loss (>10%) in the prior 3 months
- Patients with cutaneous metastasis of NSCLC
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers
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- Patients with more than 10 discrete extra/intracranial lesions
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment
- Unwillingness to participate or inability to comply with the protocol for the duration of the study
- Patients who are pregnant; patients with reproductive capability will need to use adequate contraception during the time of participation in the study
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Tereza Paračková, MD
About this study
Official title: SBRT/RT to All Sites of Disease After Three Months of First-line Systemic Chemotherapy in Oligometastatic Stage IV NSCLC Before Maintenance
The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 10 metastatic sites will improve progression-free survival (PFS) with acceptable toxicity compared to maintenance chemotherapy alone.
Read the detailed description
Lung cancer is the main cause of death from cancer in the Czech Republic and in the world. Non-small cell lung cancer (NSCLC) accounts for more than 80% of all cancer types. Lung cancer is the cause of almost five and a half thousand deaths a year in the Czech Republic, the mortality/incidence ratio is around 85%. The reason is mainly the late recognition of the tumor only in advanced stages - stage III and IV when long-term control of the disease is a rarity. In patients with advanced-stage NSCLC, chemotherapy prolongs overall survival by less than a year on average, which is still a very disappointing result. Therefore, other treatment approaches are being developed to help change this statistic. Radiotherapy (RT) also plays an important role in the treatment of lung cancer, which has a proven therapeutic benefit in both radical and palliative indications for up to 76% of all patients.
Stereotactic Robotic Radiotherapy (SBRT) achieves extraordinary precision due to the precise definition of the target volume with maximum sparing of surrounding tissues. It also allows you to focus on bearings that show movement, especially during the breathing cycle. Radiotherapy, whether conventional or stereotactic, is a non-invasive treatment method.
The aim of the study is to verify the feasibility of consolidation SBRT - CyberKnife with subsequent maintenance chemotherapy in patients in IV. The stage of non-small cell lung cancer with a maximum of 10 metastatic foci, with acceptable toxicity, while maintaining a good quality of life. The time to progression (worsening of the disease), overall survival, the number of foci with local control, the time to the appearance of new foci, the duration of maintenance chemotherapy, and the finding of predictive molecular markers of treatment response will be evaluated.
Design: prospective, interventional trial (University Hospital Ostrava) 3 months of chemotherapy platin doublet (cDDP / CBDCA + Pemetrexed, NVB) if SD/PD: RT to primary tumour + SBRT to all oligometa (max. 10 intra / extrarnial leasions, intracranial SD / PR) SBRT V < 100 ml, if technically possible fractionation RT (40 - 50 Gy / 16 - 20 fractions), SBRT (30 Gy / 1 fraction, 50 - 60 Gy / 3 - 5 fractions) 3 - 6 weeks … maintenance
Preliminary examination: PET/CT, ECHO, spirometry, MR (only if neurological symptomatology)
Endpoints:
Primary Endpoints: toxicity (CTCAE ver. 4), PFS Secondary Endpoints: OS, local control, time to new lesion, duration of maintenance chemotherapy, restriction volume according to spirometry, EF
Ad hoc analysis: PDL1 expression, Ki67 status, smoking history, KPS
Restage: every three 3 months
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Chemotherapy, Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT), Maintenance chemotherapy
- Keywords
- non small cell lung cancer, radiotherapy, stereotactic robotic radiotherapy, chemotherapy, CyberKnife, acceptable toxicity
- 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.
ChemotherapyProcedure or surgery
3 months of platinum doublet chemotherapy (cDDP / CBDCA + Pemetrexed, NVB)
Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT)Procedure or surgery
- RT to primary tumor + SBRT to all oligometa (max. 10 intra / extracranial lesions, intracranial SD / PR)
- SBRT V < 100 ml, if technically possible fractionation RT (40 - 50 Gy / 16 - 20 fractions), SBRT (30 Gy / 1 fraction, 50 - 60 Gy / 3 - 5 fractions) 3 - 6 weeks … maintenance
Maintenance chemotherapyProcedure or surgery
Maintenance chemotherapy will follow 3-6 weeks after RT.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients | Experimental | Patients with non-small cell lung cancer (NSCLC) will be enrolled in the study. Receives: Procedure: Chemotherapy; Procedure: Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT); Procedure: Maintenance chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of Toxicity
Grade of toxicity of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4
Measured: up to 12 months
Progression-Free Survival
Progression-free survival (PFS) will be observed (in months)
Measured: up to 12 months
Secondary outcomes (4)
Overall Survival
Overall survival (OS) will be observed (in months)
Measured: up to 12 months
Time to new lesion
Time to new lesion will be observed (in months)
Measured: up to 12 months)
Duration of maintenance chemotherapy
Duration of maintenance chemotherapy will be observed (in months)
Measured: up to 12 months
Restriction volume of pulmonary capacity
The restriction volume of pulmonary capacity (in %, compared to the vital capacity and total lung capacity)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Oct 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tereza Paračková, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647590
- Sponsor's protocol ID
- FNO-ONK-RT+SBRT/CHT
- Status last verified
- Jan 2024
- First submitted
- 2 Dec 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBRT/RT to All Sites of Disease After Three Months of First-line Systemic Chemotherapy in Oligometastatic Stage IV NSCLC Before Maintenance
- ClinicalTrials.gov ID
- NCT05647590
- Acronym / sponsor ID
- FNO-ONK-RT+SBRT/CHT
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- non small cell lung cancer, radiotherapy, stereotactic robotic radiotherapy, chemotherapy, CyberKnife, acceptable toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Dec 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.
The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 10 metastatic sites will improve progression-free survival (PFS) with acceptable toxicity compared to maintenance chemotherapy alone.
Detailed description
Lung cancer is the main cause of death from cancer in the Czech Republic and in the world. Non-small cell lung cancer (NSCLC) accounts for more than 80% of all cancer types. Lung cancer is the cause of almost five and a half thousand deaths a year in the Czech Republic, the mortality/incidence ratio is around 85%. The reason is mainly the late recognition of the tumor only in advanced stages - stage III and IV when long-term control of the disease is a rarity. In patients with advanced-stage NSCLC, chemotherapy prolongs overall survival by less than a year on average, which is still a very disappointing result. Therefore, other treatment approaches are being developed to help change this statistic. Radiotherapy (RT) also plays an important role in the treatment of lung cancer, which has a proven therapeutic benefit in both radical and palliative indications for up to 76% of all patients.
Stereotactic Robotic Radiotherapy (SBRT) achieves extraordinary precision due to the precise definition of the target volume with maximum sparing of surrounding tissues. It also allows you to focus on bearings that show movement, especially during the breathing cycle. Radiotherapy, whether conventional or stereotactic, is a non-invasive treatment method.
The aim of the study is to verify the feasibility of consolidation SBRT - CyberKnife with subsequent maintenance chemotherapy in patients in IV. The stage of non-small cell lung cancer with a maximum of 10 metastatic foci, with acceptable toxicity, while maintaining a good quality of life. The time to progression (worsening of the disease), overall survival, the number of foci with local control, the time to the appearance of new foci, the duration of maintenance chemotherapy, and the finding of predictive molecular markers of treatment response will be evaluated.
Design: prospective, interventional trial (University Hospital Ostrava) 3 months of chemotherapy platin doublet (cDDP / CBDCA + Pemetrexed, NVB) if SD/PD: RT to primary tumour + SBRT to all oligometa (max. 10 intra / extrarnial leasions, intracranial SD / PR) SBRT V < 100 ml, if technically possible fractionation RT (40 - 50 Gy / 16 - 20 fractions), SBRT (30 Gy / 1 fraction, 50 - 60 Gy / 3 - 5 fractions) 3 - 6 weeks … maintenance
Preliminary examination: PET/CT, ECHO, spirometry, MR (only if neurological symptomatology)
Endpoints:
Primary Endpoints: toxicity (CTCAE ver. 4), PFS Secondary Endpoints: OS, local control, time to new lesion, duration of maintenance chemotherapy, restriction volume according to spirometry, EF
Ad hoc analysis: PDL1 expression, Ki67 status, smoking history, KPS
Restage: every three 3 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC patients | Experimental | Procedure: Chemotherapy, Procedure: Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT), Procedure: Maintenance chemotherapyPatients with non-small cell lung cancer (NSCLC) will be enrolled in the study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have biopsy-proven metastatic NSCLC (Stage IV).
- Patients must have received three months of first-line chemotherapy and achieved stable disease or partial response.
- Age ≥ 18 years
- Patients must have measurable disease at baseline.
- Patients can have up to 10 discrete active extracranial/intracranial lesions identified by PET/CT or MRI scan within 8 weeks prior to the initiation of SBRT.
Key exclusion criteria (10 listed)
- Patients receiving first-line erlotinib, gefitinib, or crizotinib for EGFR mutant-positive or EML4-ALK-positive NSCLC will be excluded.
- Patients who previously received radiotherapy at the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy
- Patients with serious, uncontrolled, concurrent infection(s)
- Significant weight loss (>10%) in the prior 3 months
- Patients with cutaneous metastasis of NSCLC
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 |
|---|---|---|
| Chemotherapy3 months of platinum doublet chemotherapy (cDDP / CBDCA + Pemetrexed, NVB) | Procedure or surgery | NSCLC patients |
| Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT)* RT to primary tumor + SBRT to all oligometa (max. 10 intra / extracranial lesions, intracranial SD / PR) * SBRT V < 100 ml, if technically possible fractionation RT (40 - 50 Gy / 16 - 20 fractions), SBRT (30 Gy / 1 fraction, 50 - 60 Gy / 3 - 5 fractions) 3 - 6 weeks … maintenance | Procedure or surgery | NSCLC patients |
| Maintenance chemotherapyMaintenance chemotherapy will follow 3-6 weeks after RT. | Procedure or surgery | NSCLC patients |
Primary outcome
Grade of Toxicity
Time frame: up to 12 months
Grade of toxicity of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4
Progression-Free Survival
Time frame: up to 12 months
Progression-free survival (PFS) will be observed (in months)
4 secondary outcomes
Overall Survival
Time frame: up to 12 months
Time to new lesion
Time frame: up to 12 months)
Duration of maintenance chemotherapy
Time frame: up to 12 months
Restriction volume of pulmonary capacity
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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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.
Tereza Paračková, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy, Radiotherapy (RT) + Stereotactic Body Ratio Therapy (SBRT) and Maintenance chemotherapy in people with Non Small Cell Lung Cancer, run by University Hospital Ostrava at 1 site in Czechia.
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 10 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 30 Jan 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 Czechia. 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 Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of Toxicity (time frame: up to 12 months). 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 30 Jan 2024.