Small-cell Lung CancerPCILESSNCT04168281
Watchful Observation of Patients With LD-SCLC Instead of the PCI
A study testing Magnetic resonance imaging (MRI) in people with Small-cell Lung Cancer, run by Sergiusz Nawrocki at 1 site in Poland.
Trial summary
Prophylactic cranial irradiation (PCI) is a current standard of care after confirmed response to radical chemoradiotherapy for limited disease small cell lung cancer (LD-SCLC). This standard is mostly based on results of old randomized studies when brain imaging with magnetic resonance (MRI) was not available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- Magnetic resonance imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 2 Sep 2019to 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
- confirmed histologically small cell lung cancer, confirmed by staging limited disease SCLC, complete or good response to local chemoradiotherapy, good performance status (ECOG/WHO=0-2), signed informed consent
Who cannot join
- disseminated disease (ED-SCLC), contraindication to MRI, not able to perform cognitive function tests, poor PS (ECOG/WHO >2)
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Katedra Onkologii, Wydział Lekarski, Collegium Medicum, Uniwersytet Warmińsko-Mazurski
Olsztyn, Warmia I Mazury, 10-228
Irena Rzatkiewicz, Msc, +48 895398310, irena.rzatkiewicz@uwm.edu.pl
Anna Sugajska, MD, +48 895398310, anna.sugajska@gmail.com
About this study
Official title: Watchful Observation of Patients With Limited Small Cell Lung Cancer Instead of the PCI - Prospective, Multi-center One-arm Study
Prophylactic cranial irradiation (PCI) is a current standard of care after confirmed response to radical chemoradiotherapy for limited disease small cell lung cancer (LD-SCLC). This standard is mostly based on results of old randomized studies when brain imaging with magnetic resonance (MRI) was not available. Survival benefit of PCI in extended SCLC was recently challenged by results of randomized phase III study from Japan. We propose to carefully follow LD-SCLC patients with MRI instead of PCI in order to apply modern brain irradiation [stereotactic radiotherapy (SRT) in eligible patients or whole brain radiation therapy (WBRT)] to patients who develop metastases and to eliminate long terms neurocognitive deficits caused by PCI in patients who would never develop brain metastases.
Methods and analysis This is a prospective multi-centre one-arm trial. A total of 80 patients diagnosed with LD-SCLC after confirmed response to standard of care radical chemoradiotherapy will be enrolled. Patients will be followed-up by brain MRI every 3 months up to 3 years. Neurocognitive function tests will be performed at baseline and after 12 and 24 months. Patients who develop brain metastases during observation will be irradiated. In case of limited number and volume of metastases SRT will be offered to patients; others will be treated with WBRT. The primary endpoint of the trial is overall survival. We have assumed that our approach will not compromise overall survival of treated patients. 2-year survival will be at least 50% in our trial compared to 36% for a group of 138 patients LD-SCLC from our institution treated in 2003-2006 with radical chemoradiotherapy and PCI. The secondary endpoints were designed to asses the risk of developing brain metastases without PCI; to assess the efficacy of radiotherapy of early detected brain metastases, including the feasibility and efficacy of SRT; to assess neurocognitive functions and QoL in the studied cohort. QLQ-C30 questionnaire and the California Verbal Learning Test (CVLT), Color connection test (CTT), Benton visual memory test (BNRT) and Verbal fluency test (VFT) will be carried out by the certified psychologist.
Ethics and dissemination The trial received ethical approval from the local medical university Bioethical Review Board (Komisja Bioetyczna Collegium Medicum Uniwersytet Warmińsko-Mazurski w Olsztynie). The results of the trial will be disseminated through peer-reviewed publications and conference presentations.
Read the detailed description
Patients with diagnosed LD-SCLC, after radical treatment with remission or at least a good response after radical therapy, will be eligible for the study. Patients would have had radical radiotherapy to the chest with chemotherapy according to current international guidelines and institutional protocols. A detailed medical history will be collected regarding SCLC and comorbidities. During the qualification visit, the remission or good response should be confirmed based on chest/abdomen/pelvis CT examinations. After obtaining the patient's informed consent to participate in the clinical trial, a brain MRI (MRI-1) will be performed and a baseline assessment of cognitive functions will be carried out using the battery of test listed below.
Patients who at MRI-1 will be diagnosed with cerebral metastasis, depending on the size and number of lesions will be eligible for WBRT (whole brain irradiation) or SRT (brain stereotactic radiotherapy). We propose SRT eligibility treatment criteria as in NSCLC according to the standards of the participating centers. All participating radiotherapy centers must have experience in SRT of brain metastases and up to date radiotherapy equipment suitable for SRT. Subjects who will not have cerebral metastases in the MRI-1 after chemo-radiotherapy will have their next follow-up every 3 months (+/- 2 weeks) up to 2 years, and then every 6 months (+/- 2 weeks) up to 3 years.
At the qualifying visit before MRI-1, and then every 6 months +/- 2 weeks), the patients will have a cognitive examination performed using dedicated neuropsychological tests and QoL assessment using the QLQ-C30 questionnaire. The tests will be conducted in the following order: California verbal learning test (CVLT) with a delay of 15 min, Color connection test (CTT), CVLT (after delay), Benton visual memory test (BNRT), Verbal fluency test by the certified psychologist.
- Conditions
- Small-cell Lung Cancer
- Being tested
- Magnetic resonance imaging (MRI)
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Diagnostic test
instead of PCI patients will be followed-up with MRI
| Study group | Role | What they receive |
|---|---|---|
| PCI- free after response to radical chemoradiotherapy | Experimental | Patients with no metastases will be followed-up with MRI: at the qualifying visit before MRI-1, and then every 6 months +/- 2 weeks), the patients will have a cognitive examination performed using dedicated neuropsychological tests and QoL assessment using the QLQ-C30 questionnaire. The tests will be conducted in the following order: California verbal learning test (CVLT) with a delay of 15 min, Color connection test (CTT), CVLT (after delay), Benton visual memory test (BNRT), Verbal fluency test by the certified psychologist. Receives: Diagnostic Test: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start2 Sep 2019
- 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 (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- deescalation of treatment - watchful observation instead of Whole Brain Irradiation
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sergiusz Nawrocki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sergiusz Nawrocki, University of Warmia and Mazury in Olsztyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168281
- Sponsor's protocol ID
- LD-SCLC_PCI
- Acronym
- PCILESS
- Status last verified
- Nov 2019
- First submitted
- 16 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nawrocki S, Sugajska A. Study protocol: watchful observation of patients with limited small cell lung cancer instead of the PCI-prospective, multi-center one-arm study. BMC Cancer. 2020 Mar 18;20(1):231. doi: 10.1186/s12885-020-06721-8.
PubMed 32188425
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watchful Observation of Patients With Limited Small Cell Lung Cancer Instead of the PCI - Prospective, Multi-center One-arm Study
- ClinicalTrials.gov ID
- NCT04168281
- Acronym / sponsor ID
- PCILESS / LD-SCLC_PCI
- Conditions
- Small-cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sergiusz NawrockiUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Nov 2019 (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.
Prophylactic cranial irradiation (PCI) is a current standard of care after confirmed response to radical chemoradiotherapy for limited disease small cell lung cancer (LD-SCLC). This standard is mostly based on results of old randomized studies when brain imaging with magnetic resonance (MRI) was not available. Survival benefit of PCI in extended SCLC was recently challenged by results of randomized phase III study from Japan. We propose to carefully follow LD-SCLC patients with MRI instead of PCI in order to apply modern brain irradiation [stereotactic radiotherapy (SRT) in eligible patients or whole brain radiation therapy (WBRT)] to patients who develop metastases and to eliminate long terms neurocognitive deficits caused by PCI in patients who would never develop brain metastases.
Methods and analysis This is a prospective multi-centre one-arm trial. A total of 80 patients diagnosed with LD-SCLC after confirmed response to standard of care radical chemoradiotherapy will be enrolled. Patients will be followed-up by brain MRI every 3 months up to 3 years. Neurocognitive function tests will be performed at baseline and after 12 and 24 months. Patients who develop brain metastases during observation will be irradiated. In case of limited number and volume of metastases SRT will be offered to patients; others will be treated with WBRT. The primary endpoint of the trial is overall survival. We have assumed that our approach will not compromise overall survival of treated patients. 2-year survival will be at least 50% in our trial compared to 36% for a group of 138 patients LD-SCLC from our institution treated in 2003-2006 with radical chemoradiotherapy and PCI. The secondary endpoints were designed to asses the risk of developing brain metastases without PCI; to assess the efficacy of radiotherapy of early detected brain metastases, including the feasibility and efficacy of SRT; to assess neurocognitive functions and QoL in the studied cohort. QLQ-C30 questionnaire and the California Verbal Learning Test (CVLT), Color connection test (CTT), Benton visual memory test (BNRT) and Verbal fluency test (VFT) will be carried out by the certified psychologist.
Ethics and dissemination The trial received ethical approval from the local medical university Bioethical Review Board (Komisja Bioetyczna Collegium Medicum Uniwersytet Warmińsko-Mazurski w Olsztynie). The results of the trial will be disseminated through peer-reviewed publications and conference presentations.
Detailed description
Patients with diagnosed LD-SCLC, after radical treatment with remission or at least a good response after radical therapy, will be eligible for the study. Patients would have had radical radiotherapy to the chest with chemotherapy according to current international guidelines and institutional protocols. A detailed medical history will be collected regarding SCLC and comorbidities. During the qualification visit, the remission or good response should be confirmed based on chest/abdomen/pelvis CT examinations. After obtaining the patient's informed consent to participate in the clinical trial, a brain MRI (MRI-1) will be performed and a baseline assessment of cognitive functions will be carried out using the battery of test listed below.
Patients who at MRI-1 will be diagnosed with cerebral metastasis, depending on the size and number of lesions will be eligible for WBRT (whole brain irradiation) or SRT (brain stereotactic radiotherapy). We propose SRT eligibility treatment criteria as in NSCLC according to the standards of the participating centers. All participating radiotherapy centers must have experience in SRT of brain metastases and up to date radiotherapy equipment suitable for SRT. Subjects who will not have cerebral metastases in the MRI-1 after chemo-radiotherapy will have their next follow-up every 3 months (+/- 2 weeks) up to 2 years, and then every 6 months (+/- 2 weeks) up to 3 years.
At the qualifying visit before MRI-1, and then every 6 months +/- 2 weeks), the patients will have a cognitive examination performed using dedicated neuropsychological tests and QoL assessment using the QLQ-C30 questionnaire. The tests will be conducted in the following order: California verbal learning test (CVLT) with a delay of 15 min, Color connection test (CTT), CVLT (after delay), Benton visual memory test (BNRT), Verbal fluency test by the certified psychologist.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- deescalation of treatment - watchful observation instead of Whole Brain Irradiation
| Arm | Type | Receives |
|---|---|---|
| PCI- free after response to radical chemoradiotherapy | Experimental | Diagnostic Test: Magnetic resonance imaging (MRI)Patients with no metastases will be followed-up with MRI: at the qualifying visit before MRI-1, and then every 6 months +/- 2 weeks), the patients will have a cognitive examination performed using dedicated neuropsychological tests and QoL assessment using the QLQ-C30 questionnaire. The tests will be conducted in the following order: California verbal learning test (CVLT) with a delay of 15 min, Color connection test (CTT), CVLT (after delay), Benton visual memory test (BNRT), Verbal fluency test by the certified psychologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- confirmed histologically small cell lung cancer, confirmed by staging limited disease SCLC, complete or good response to local chemoradiotherapy, good performance status (ECOG/WHO=0-2), signed informed consent
Key exclusion criteria (1 listed)
- disseminated disease (ED-SCLC), contraindication to MRI, not able to perform cognitive function tests, poor PS (ECOG/WHO >2)
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 |
|---|---|---|
| Magnetic resonance imaging (MRI)instead of PCI patients will be followed-up with MRI | Diagnostic test | PCI- free after response to radical chemoradiotherapy |
Primary outcome
Overall Survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Derived from this study: PubMed 32188425Nawrocki S, Sugajska A. Study protocol: watchful observation of patients with limited small cell lung cancer instead of the PCI-prospective, multi-center one-arm study. BMC Cancer. 2020 Mar 18;20(1):231. doi: 10.1186/s12885-020-06721-8.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging (MRI) in people with Small-cell Lung Cancer, run by Sergiusz Nawrocki at 1 site in Poland.
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 1 inclusion and 1 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 19 Nov 2019. 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 Poland. 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 Sergiusz Nawrocki, MD, PhD (+48 895398310, sergiusz.nawrocki@uwm.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 24 months). 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 NCT04168281, which also lists 1 linked publication.
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 19 Nov 2019.