Non-small Cell Lung CancerNCT04758481
Consolidation Conventional Radiotherapy + Stereotactic Body Radiotherapy at 3 Months After First-line Chemotherapy in Stage IV Oligometastatic Non-small Cell Lung Cancer
A study testing primary tumour radiotherapy, stereotactic body radiotherapy and maintenance radiotherapy in people with Non-small Cell Lung Cancer, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Lung cancer is the main cause of death among cancer diseases, in the Czech Republic, as well as worldwide. Non-small cell lung cancer (NSCLC) is responsible for more than 80% of deaths among cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- primary tumour radiotherapy, stereotactic body radiotherapy and maintenance radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 4 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with previously untreated, non-resectable, stage IV NSCLC verified with histology or cytology (according to American Joint Committee on Cancer Version 8).
- Patients must undergo 2-4 cycles of first-line chemotherapy, with the effect of disease stabilization or partial response.
- Patients over 18 years of age.
- Patients with measureable disease (on CT, PET/CT, MRI).
- Patients with 3-10 extracranial/intracranial lesions confirmed on CT, PET/CT, MRI, max. 4 weeks prior to start of SBRT.
- Max. 10 irradiated volumes (primary tumour + lymphadenopathy in one volume, if technically feasible).
Show all 13Show fewer
- Performance status (PS) 0-2 according to ECOG. Assessment of PS max. 7 days prior to start of treatment.
- AST, ALT \& ALP ≤ 2.5x norm. Total bilirubin must be within the normal range. 9. Normal function of bone marrow - Adiponectin ≥ 1.5, Haemoglobin ≥ 100, thrombo ≥ 100.
- Serum creatinine ≤1.5x norm.
- The entry laboratory tests must not be older than 14 days prior to start of treatment.
- Negative pregnancy test and use of contraception in women of childbearing age.
- Patients undergoing SBRT for pulmonary nidi must undergo entry spirometry with the value FEV1 (forced expiratory volume in 1 second) ≥ 1L.
- Patients must sign informed consent.
Who cannot join
- Patients with small-cell lung cancer or with mixed aetiology with SCLC.
- Serious ongoing infections.
- Patients with a history of haematopoiesis disorders.
- Weight loss exceeding 10% within the last 3 months.
- Patients with skin metastases of NSCLC.
- Patients treated for other malignity within the last 5 years
Show all 14Show fewer
- Patients with more than 10 extracranial/intracranial metastases.
- Malignant fluidothorax > 1 cm prior to start of treatment.
- Patients treated with targeted treatment for EGFR mutation or EML-4-ALK translocation in the 1st-line (Erlotinib, Gefitinib, Afatinib, Crizotinib, …).
- Patients treated with immunotherapy (anti-PD-1, anti-PD-L1 or anti-PD-L2, anti CTLA-4, …).
- Participation in another clinical trial within the last month before the start of NSCLC treatment.
- Inability to cooperate or comply with the study protocol.
- Decision of the patient to discontinue participation in the study.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059773 ext. 2587, jiri.hyncica@fno.cz
Tereza Paračková, MD
About this study
Official title: Consolidation Conventional Radiotherapy + Stereotactic Body Radiotherapy of All Body Locations With the Disease at 3 Months After First Line Chemotherapy in Stage IV Oligometastatic Non-small Cell Lung Cancer, Prior to Maintenance Therapy
Lung cancer is the main cause of death among cancer diseases, in the Czech Republic, as well as worldwide. Non-small cell lung cancer (NSCLC) is responsible for more than 80% of deaths among cancer patients. Bronchogenic carcinoma is the reason of death of almost 5.500 cases every year in the Czech Republic, the mortality/incidence ration varies around 85%. The main cause for these unfavorable findings is the late detection of the carcinoma in late stages only (III and IV), when a long-term control of the disease is exceptional. Chemotherapy is able to prolong the life of patients with NSCLC by less than one year on average, that is why new treatment approaches are being examined.
Read the detailed description
The basic treatment modality of lung cancer is radiotherapy, which has a proven therapeutic benefit in radical and palliative indications in up to 76% of all patients. Stereotactic robotic radiotherapy reaches maximum precision due to the precise definition of the target volume. In some localities, management with images has been solved using modern software instruments, which are able to visualize the tumor and monitor it during the whole course of respiratory cycle. This is directly associated with minimizing radiation of healthy tissues, especially the healthy lung parenchyma. In order to define predictive factors of survival of cancer patients, it is necessary to use molecular markers.
The aim of the study is to verify the feasibility of consolidation SBRT (Stereotactic Body RadioTherapy) - CyberKnife, with subsequent maintenance chemotherapy in patients with stage IV NSCLC, with max. 10 metastatic nidi. The main focus of the study will be on assessment of combination treatment toxicity.
The project is a phase I/II non-randomized clinical trial. Patients with stage IV NSCLC will be treated with 2-4 cycles of chemotherapy - platinum doublet (cisplatinum - cDDP/carboplatinum - CBDCA + Pemetrexed/navelibne - NVB). In cases when disease stabilization (SD)/partial resection (PR) will be achieved, based upon restaging examinations (CT), radiotherapy (RT) of the primary tumour will follow, with lymphadenopathy and SBRT of all metastatic nidi (max. 10 intra- or extracranial metastases). Standard fractionation schemes for RT and SBRT will be used (RT 40-50 Gy/16-20 fractions, SBRT 30 Gy/1 fractionation, 50-60 Gy/3-5 fractionations). At 3-6 weeks after the end of RT, maintenance treatment will be initiated in all patients treated with Peterexed. Regular restaging examinations are planned every 3 months.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- primary tumour radiotherapy, stereotactic body radiotherapy, maintenance radiotherapy
- Keywords
- non-small cell lung cancer, stereotactic body radiotherapy, CyberKnife, maintenance 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.
primary tumour radiotherapyRadiation
The study subjects will undergo primary tumour radiotherapy.
stereotactic body radiotherapyRadiation
The study subjects will undergo stereotactic body radiotherapy.
maintenance radiotherapyRadiation
The study subjects will undergo maintenance radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy | Experimental | The patients, in whom disease stabilisation/partial regression will be achieved, will undergo primary tumour radiotherapy and stereotactic body radiotherapy, followed with maintenance radiotherapy. Receives: Radiation: primary tumour radiotherapy; Radiation: stereotactic body radiotherapy; Radiation: maintenance radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and late toxicity
Acute and late toxicity of the combination therapy will be observed (according to Common Terminology for Clinical Adverse Event (CTCAE, version 5)
Measured: every 3 months, throughout the study duration, up to 32 months in total
Progression-free survival
Progression-free survival will be observed
Measured: every 3 months
Secondary outcomes (4)
Overall survival
Overall survival will be observed
Measured: every 3 months, throughout the study duration, up to 32 months in total
Share of nidi under local control
The share of nidi under local control will be observed (in per cent/total number of nidi)
Measured: every 3 months, throughout the study duration, up to 32 months in total
Time to new nidus formation
The time to new nidus formation will be observed
Measured: every 3 months, throughout the study duration, up to 32 months in total
Duration of maintenance chemotherapy
The duration of maintenance chemotherapy will be observed.
Measured: every 3 months, throughout the study duration, up to 32 months in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start4 May 2021
- 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.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Model description
- This is a non-randomised study with the primary intent to treat patients with NSCLC
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT04758481
- Sponsor's protocol ID
- RVO-FNOs/2020-22
- Status last verified
- Dec 2022
- First submitted
- 4 Feb 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the individual participant data with other researchers; the data may be provided upon request.
Publications
Siva S, MacManus M, Ball D. Stereotactic radiotherapy for pulmonary oligometastases: a systematic review. J Thorac Oncol. 2010 Jul;5(7):1091-9. doi: 10.1097/JTO.0b013e3181de7143.
PubMed 20479693Onishi H, Shirato H, Nagata Y, Hiraoka M, Fujino M, Gomi K, Karasawa K, Hayakawa K, Niibe Y, Takai Y, Kimura T, Takeda A, Ouchi A, Hareyama M, Kokubo M, Kozuka T, Arimoto T, Hara R, Itami J, Araki T. Stereotactic body radiotherapy (SBRT) for operable stage I non-small-cell lung cancer: can SBRT be comparable to surgery? Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1352-8. doi: 10.1016/j.ijrobp.2009.07.1751. Epub 2010 Jul 16.
PubMed 20638194Takeda A, Kunieda E, Ohashi T, Aoki Y, Koike N, Takeda T. Stereotactic body radiotherapy (SBRT) for oligometastatic lung tumors from colorectal cancer and other primary cancers in comparison with primary lung cancer. Radiother Oncol. 2011 Nov;101(2):255-9. doi: 10.1016/j.radonc.2011.05.033.
PubMed 21641064Collen C, Christian N, Schallier D, Meysman M, Duchateau M, Storme G, De Ridder M. Phase II study of stereotactic body radiotherapy to primary tumor and metastatic locations in oligometastatic nonsmall-cell lung cancer patients. Ann Oncol. 2014 Oct;25(10):1954-1959. doi: 10.1093/annonc/mdu370. Epub 2014 Aug 11.
PubMed 25114022Norihisa Y, Nagata Y, Takayama K, Matsuo Y, Sakamoto T, Sakamoto M, Mizowaki T, Yano S, Hiraoka M. Stereotactic body radiotherapy for oligometastatic lung tumors. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):398-403. doi: 10.1016/j.ijrobp.2008.01.002. Epub 2008 Apr 18.
PubMed 18374506Guerrero E, Ahmed M. The role of stereotactic ablative radiotherapy (SBRT) in the management of oligometastatic non small cell lung cancer. Lung Cancer. 2016 Feb;92:22-8. doi: 10.1016/j.lungcan.2015.11.015. Epub 2015 Dec 2.
PubMed 26775592Oh D, Ahn YC, Seo JM, Shin EH, Park HC, Lim DH, Pyo H. Potentially curative stereotactic body radiation therapy (SBRT) for single or oligometastasis to the lung. Acta Oncol. 2012 May;51(5):596-602. doi: 10.3109/0284186X.2012.681698. Epub 2012 May 1.
PubMed 22548366Singh D, Chen Y, Hare MZ, Usuki KY, Zhang H, Lundquist T, Joyce N, Schell MC, Milano MT. Local control rates with five-fraction stereotactic body radiotherapy for oligometastatic cancer to the lung. J Thorac Dis. 2014 Apr;6(4):369-74. doi: 10.3978/j.issn.2072-1439.2013.12.03.
PubMed 24688781Lussier YA, Xing HR, Salama JK, Khodarev NN, Huang Y, Zhang Q, Khan SA, Yang X, Hasselle MD, Darga TE, Malik R, Fan H, Perakis S, Filippo M, Corbin K, Lee Y, Posner MC, Chmura SJ, Hellman S, Weichselbaum RR. MicroRNA expression characterizes oligometastasis(es). PLoS One. 2011;6(12):e28650. doi: 10.1371/journal.pone.0028650. Epub 2011 Dec 13.
PubMed 22174856Wong AC, Watson SP, Pitroda SP, Son CH, Das LC, Stack ME, Uppal A, Oshima G, Khodarev NN, Salama JK, Weichselbaum RR, Chmura SJ. Clinical and molecular markers of long-term survival after oligometastasis-directed stereotactic body radiotherapy (SBRT). Cancer. 2016 Jul 15;122(14):2242-50. doi: 10.1002/cncr.30058. Epub 2016 May 20.
PubMed 27206146
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidation Conventional Radiotherapy + Stereotactic Body Radiotherapy of All Body Locations With the Disease at 3 Months After First Line Chemotherapy in Stage IV Oligometastatic Non-small Cell Lung Cancer, Prior to Maintenance Therapy
- ClinicalTrials.gov ID
- NCT04758481
- Acronym / sponsor ID
- RVO-FNOs/2020-22
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, stereotactic body radiotherapy, CyberKnife, maintenance radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Feb 2021 (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 the main cause of death among cancer diseases, in the Czech Republic, as well as worldwide. Non-small cell lung cancer (NSCLC) is responsible for more than 80% of deaths among cancer patients. Bronchogenic carcinoma is the reason of death of almost 5.500 cases every year in the Czech Republic, the mortality/incidence ration varies around 85%. The main cause for these unfavorable findings is the late detection of the carcinoma in late stages only (III and IV), when a long-term control of the disease is exceptional. Chemotherapy is able to prolong the life of patients with NSCLC by less than one year on average, that is why new treatment approaches are being examined.
Detailed description
The basic treatment modality of lung cancer is radiotherapy, which has a proven therapeutic benefit in radical and palliative indications in up to 76% of all patients. Stereotactic robotic radiotherapy reaches maximum precision due to the precise definition of the target volume. In some localities, management with images has been solved using modern software instruments, which are able to visualize the tumor and monitor it during the whole course of respiratory cycle. This is directly associated with minimizing radiation of healthy tissues, especially the healthy lung parenchyma. In order to define predictive factors of survival of cancer patients, it is necessary to use molecular markers.
The aim of the study is to verify the feasibility of consolidation SBRT (Stereotactic Body RadioTherapy) - CyberKnife, with subsequent maintenance chemotherapy in patients with stage IV NSCLC, with max. 10 metastatic nidi. The main focus of the study will be on assessment of combination treatment toxicity.
The project is a phase I/II non-randomized clinical trial. Patients with stage IV NSCLC will be treated with 2-4 cycles of chemotherapy - platinum doublet (cisplatinum - cDDP/carboplatinum - CBDCA + Pemetrexed/navelibne - NVB). In cases when disease stabilization (SD)/partial resection (PR) will be achieved, based upon restaging examinations (CT), radiotherapy (RT) of the primary tumour will follow, with lymphadenopathy and SBRT of all metastatic nidi (max. 10 intra- or extracranial metastases). Standard fractionation schemes for RT and SBRT will be used (RT 40-50 Gy/16-20 fractions, SBRT 30 Gy/1 fractionation, 50-60 Gy/3-5 fractionations). At 3-6 weeks after the end of RT, maintenance treatment will be initiated in all patients treated with Peterexed. Regular restaging examinations are planned every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a non-randomised study with the primary intent to treat patients with NSCLC
| Arm | Type | Receives |
|---|---|---|
| Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy | Experimental | Radiation: primary tumour radiotherapy, Radiation: stereotactic body radiotherapy, Radiation: maintenance radiotherapyThe patients, in whom disease stabilisation/partial regression will be achieved, will undergo primary tumour radiotherapy and stereotactic body radiotherapy, followed with maintenance radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with previously untreated, non-resectable, stage IV NSCLC verified with histology or cytology (according to American Joint Committee on Cancer Version 8).
- Patients must undergo 2-4 cycles of first-line chemotherapy, with the effect of disease stabilization or partial response.
- Patients over 18 years of age.
- Patients with measureable disease (on CT, PET/CT, MRI).
- Patients with 3-10 extracranial/intracranial lesions confirmed on CT, PET/CT, MRI, max. 4 weeks prior to start of SBRT.
Key exclusion criteria (14 listed)
- Patients with small-cell lung cancer or with mixed aetiology with SCLC.
- Serious ongoing infections.
- Patients with a history of haematopoiesis disorders.
- Weight loss exceeding 10% within the last 3 months.
- Patients with skin metastases 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 |
|---|---|---|
| primary tumour radiotherapyThe study subjects will undergo primary tumour radiotherapy. | Radiation | Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy |
| stereotactic body radiotherapyThe study subjects will undergo stereotactic body radiotherapy. | Radiation | Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy |
| maintenance radiotherapyThe study subjects will undergo maintenance radiotherapy. | Radiation | Primary tumour radiotherapy + stereotactic body radiotherapy + maintenance radiotherapy |
Primary outcome
Acute and late toxicity
Time frame: every 3 months, throughout the study duration, up to 32 months in total
Acute and late toxicity of the combination therapy will be observed (according to Common Terminology for Clinical Adverse Event (CTCAE, version 5)
Progression-free survival
Time frame: every 3 months
Progression-free survival will be observed
4 secondary outcomes
Overall survival
Time frame: every 3 months, throughout the study duration, up to 32 months in total
Share of nidi under local control
Time frame: every 3 months, throughout the study duration, up to 32 months in total
Time to new nidus formation
Time frame: every 3 months, throughout the study duration, up to 32 months in total
Duration of maintenance chemotherapy
Time frame: every 3 months, throughout the study duration, up to 32 months in total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Background: PubMed 20479693Siva S, MacManus M, Ball D. Stereotactic radiotherapy for pulmonary oligometastases: a systematic review. J Thorac Oncol. 2010 Jul;5(7):1091-9. doi: 10.1097/JTO.0b013e3181de7143.
- Background: PubMed 20638194Onishi H, Shirato H, Nagata Y, Hiraoka M, Fujino M, Gomi K, Karasawa K, Hayakawa K, Niibe Y, Takai Y, Kimura T, Takeda A, Ouchi A, Hareyama M, Kokubo M, Kozuka T, Arimoto T, Hara R, Itami J, Araki T. Stereotactic body radiotherapy (SBRT) for operable stage I non-small-cell lung cancer: can SBRT be comparable to surgery? Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1352-8. doi: 10.1016/j.ijrobp.2009.07.1751. Epub 2010 Jul 16.
- Background: PubMed 21641064Takeda A, Kunieda E, Ohashi T, Aoki Y, Koike N, Takeda T. Stereotactic body radiotherapy (SBRT) for oligometastatic lung tumors from colorectal cancer and other primary cancers in comparison with primary lung cancer. Radiother Oncol. 2011 Nov;101(2):255-9. doi: 10.1016/j.radonc.2011.05.033.
- Background: PubMed 25114022Collen C, Christian N, Schallier D, Meysman M, Duchateau M, Storme G, De Ridder M. Phase II study of stereotactic body radiotherapy to primary tumor and metastatic locations in oligometastatic nonsmall-cell lung cancer patients. Ann Oncol. 2014 Oct;25(10):1954-1959. doi: 10.1093/annonc/mdu370. Epub 2014 Aug 11.
- Background: PubMed 18374506Norihisa Y, Nagata Y, Takayama K, Matsuo Y, Sakamoto T, Sakamoto M, Mizowaki T, Yano S, Hiraoka M. Stereotactic body radiotherapy for oligometastatic lung tumors. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):398-403. doi: 10.1016/j.ijrobp.2008.01.002. Epub 2008 Apr 18.
- Background: PubMed 26775592Guerrero E, Ahmed M. The role of stereotactic ablative radiotherapy (SBRT) in the management of oligometastatic non small cell lung cancer. Lung Cancer. 2016 Feb;92:22-8. doi: 10.1016/j.lungcan.2015.11.015. Epub 2015 Dec 2.
- Background: PubMed 22548366Oh D, Ahn YC, Seo JM, Shin EH, Park HC, Lim DH, Pyo H. Potentially curative stereotactic body radiation therapy (SBRT) for single or oligometastasis to the lung. Acta Oncol. 2012 May;51(5):596-602. doi: 10.3109/0284186X.2012.681698. Epub 2012 May 1.
- Background: PubMed 24688781Singh D, Chen Y, Hare MZ, Usuki KY, Zhang H, Lundquist T, Joyce N, Schell MC, Milano MT. Local control rates with five-fraction stereotactic body radiotherapy for oligometastatic cancer to the lung. J Thorac Dis. 2014 Apr;6(4):369-74. doi: 10.3978/j.issn.2072-1439.2013.12.03.
- Background: PubMed 22174856Lussier YA, Xing HR, Salama JK, Khodarev NN, Huang Y, Zhang Q, Khan SA, Yang X, Hasselle MD, Darga TE, Malik R, Fan H, Perakis S, Filippo M, Corbin K, Lee Y, Posner MC, Chmura SJ, Hellman S, Weichselbaum RR. MicroRNA expression characterizes oligometastasis(es). PLoS One. 2011;6(12):e28650. doi: 10.1371/journal.pone.0028650. Epub 2011 Dec 13.
- Background: PubMed 27206146Wong AC, Watson SP, Pitroda SP, Son CH, Das LC, Stack ME, Uppal A, Oshima G, Khodarev NN, Salama JK, Weichselbaum RR, Chmura SJ. Clinical and molecular markers of long-term survival after oligometastasis-directed stereotactic body radiotherapy (SBRT). Cancer. 2016 Jul 15;122(14):2242-50. doi: 10.1002/cncr.30058. Epub 2016 May 20.
- Individual participant dataSharing planned: No. There is no plan to share the individual participant data with 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 primary tumour radiotherapy, stereotactic body radiotherapy and maintenance radiotherapy 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 13 inclusion and 14 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 7 Dec 2022. 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?
Acute and late toxicity (time frame: every 3 months, throughout the study duration, up to 32 months in total). 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?
On the ClinicalTrials.gov record for NCT04758481, which also lists 10 linked publications.
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 7 Dec 2022.